National Diabetes Foot Care Audit Report

2014-2015

England and Wales

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Author: Clinical Audit and Registries Management Service Health and Social Care Information Centre

Version: V1.0

Date of publication:

31 March 2016

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Prepared in collaboration with:

The Healthcare Quality Improvement Partnership (HQIP). The National Diabetes Foot Care Audit is commissioned by the Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical Audit Programme (NCA). HQIP is led by a consortium of the Academy of Medical Royal Colleges, the Royal College of Nursing and National Voices. Its aim is to promote quality improvement, and in particular to increase the impact that clinical audit has on healthcare quality in England and Wales. HQIP holds the contract to manage and develop the NCA Programme, comprising more than 30 clinical audits that cover care provided to people with a wide range of medical, surgical and mental health conditions. The programme is funded by NHS England, the Welsh Government and, with some individual audits, also funded by the Health Department of the Scottish Government, DHSSPS Northern Ireland and the Channel Islands.

The Health and Social Care Information Centre (HSCIC) is the trusted source of authoritative data and information relating to health and care. The HSCIC managed the publication of the 2014-2015 annual report.

Diabetes UK is the largest organisation in the UK working for people with diabetes, funding research, campaigning and helping people live with the condition.

Supported by:

The national cardiovascular intelligence network (NCVIN) is a partnership of leading national cardiovascular organisations which analyses information and data and turns it into meaningful timely health intelligence for commissioners, policy makers, clinicians and health professionals to improve services and outcomes.

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Contents Acknowledgements 6

Foreword 8

Executive summary 9

Key messages 9

Key findings 9

Recommendations 11

Introduction 12

Background 12

Data collection 13

Participation 13

NDFA patient pathway from development of ulcer 14

Participation – Results and Findings 15

NDFA Structures Survey 15

NDFA processes and outcomes collection 15

NDFA submissions 16

Case ascertainment 17

Linkage to the core National Diabetes Audit 17

Characteristics of people with diabetes presenting with foot ulcers – Results and Findings 18

Structure - Results and Findings 19

Service provision and commissioners 19

Processes – Results and Findings 20

Foot risk assessment 20

Ulcer characteristics and time to first assessment 21

Index and multiple ulcers 21

Charcot foot disease 21

Ulcer severity 22

Time to first assessment 23

Time to first assessment and ulcer severity 24

Foot protection service referral pathway and ulcer severity 25

Audit Outcomes – Being ‘Ulcer Free’ at 12 Weeks – Results and Findings 26

Being ulcer free at 12 weeks and referral pathway for assessment within 24 hours 27

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Being ulcer free at 12 weeks and time to first assessment 27

Being ulcer free at 12 weeks and ulcer severity 28

Being ulcer free at 12 weeks and variation between providers 30

Being ulcer free at 12 weeks and regression modelling 32

Discussion and future plans 33

Further information 35

References 36

Appendix 1: Methodology 37

Data collection 37

NDFA Structures Survey 37

NDFA presentation and outcomes 37

Linkage to other sources 38

National Diabetes Audit 38

Hospital Episode Statistics and Patient Episode Database for Wales 38

Terminology 39

Patients and ulcers 39

Organisations 39

Analysis 40

Denominators 40

Deprivation and geography 40

Observed and case-mix adjusted results 40

Appendix 2: NDFA Structures Survey 41

Appendix 3: Participating foot care services 42

Appendix 4: Locations of participating foot care services 47

Appendix 5: Participating commissioning organisations 48

Appendix 6: NDA data items collected via linkage 55

Appendix 7: SINBAD scores 55

Appendix 8: Regression modelling of 12 week outcomes 56

Appendix 9: Characteristics of people in the NDFA 59

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Acknowledgements

Development and delivery of the National Diabetes Foot Care Audit (NDFA) is guided by a multi-professional advisory group of clinicians and patient representatives, chaired by Professor William Jeffcoate. Our thanks also go to Arthur Yelland, Claire Meace and Peter Knighton at the Health and Social Care Information Centre (HSCIC) for producing the analysis in this report, as well as Tom Latham and Anna Duggan at the HSCIC and Laura Fargher and Sophie Colling at Diabetes UK for managing the audit. The NDFA Advisory Group members include: William Jeffcoate Consultant Diabetologist, Nottingham University Hospitals NHS Trust (Chair) Bob Young Consultant Diabetologist & National Clinical Lead for the National Diabetes Audit (NDA) Roger Gadsby GP Clinical Lead, NDA Catherine Gooday Podiatrist, Norfolk & Norwich University Hospital and Foot in Diabetes UK Gerry Rayman Consultant Diabetologist, Ipswich Hospital NHS Trust Ian Loftus Consultant Vascular Surgeon, St George’s/Chair National Vascular Registry Rhys Thomas Consultant Orthopaedic Surgeon, University Hospital Llandough Michelle Goodeve Diabetes Lead Podiatrist, Broomfield Hospital, Chelmsford Alexandra Harrington Podiatrist, Gloucester Care Services NHS Trust Hana Rous Patient Representative Naomi Holman / Emma Barron Head of Health Intelligence (Diabetes), NCVIN, Public Health England Sue Brown Patient representative Roy Johnson Patient representative

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Arthur Yelland Senior Information Analyst, Health and Social Care Information Centre Tom Latham Audit Manager, Health and Social Care Information Centre Anna Duggan Audit Coordinator, Health and Social Care Information Centre Laura Fargher NDA Engagement Manager, Diabetes UK Sophie Colling NDA Project Support Officer, Diabetes UK

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Foreword

The impact of diabetic foot disease on people with diabetes is profound. It can be associated with disability, amputation and premature mortality. Its cost to the health service is considerable. Reassuringly, over the last ten years or so, we have seen much greater appreciation of the significance of diabetic foot disease, with strategies for its prevention and management the subject of repeated NICE guidelines. Although the National Diabetes Audit (NDA) has from its inception included data on annual foot risk checks and rates of amputation, there has been no measurement system for the steps in between – the development and management of foot ulcers. I welcome this first report of the National Diabetes Foot Care Audit (NDFA), which for the first time provides measurements as to whether the NICE recommended clinical pathways are in place locally and how effective those pathways are in managing new diabetic foot ulcers. Future NDFA reports will also include detail on the incidence of ulcer recurrence, hospital admission, amputation and mortality. It is encouraging that so many services (129) have participated in this first NDFA. Although the NDA team have tried to limit the local burden, it still requires appreciable commitment and organisation to take part. But the benefit of being able to benchmark referral pathways and healing times against peer services will provide much needed rigour and focus to local improvement efforts. This is clearly needed, and the NDFA shines a spotlight on key system challenges in this area such as provision of expert teams, delays in reaching expert teams and the impact of delays on healing times, ulcer severity and amputation. This first round suggests that there may be appreciable variations in all of these key parameters and suggests that there are substantial opportunities for improvement. Many of the most beneficial changes will likely require better multidisciplinary cross-organisational effort. I am grateful to the NDA team for establishing this important national audit, and of course extremely grateful to the local teams that have worked hard to provide the data for analysis. We can now look forward to witnessing the improvement programmes that should follow, so that future results can document improvement in the outcomes for people with diabetic foot disease.

Professor Jonathan Valabhji National Clinical Director for Obesity and Diabetes, NHS England Consultant Diabetologist, Imperial College Healthcare NHS Trust Adjunct Professor, Imperial College London

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Executive summary

Key messages The first cycle of the NDFA includes data on over 5,000 people presenting with a new diabetic foot ulcer episode between 14 July 2014 and 10 April 2015. Almost 130 clinical foot care teams participated and 129 Clinical Commissioning Groups (CCGs) and Local Health Boards (LHBs) contributed to the NDFA Structures Survey.

Although estimated case ascertainment is low (10 per cent), the data collected in the first nine months of the new audit has provided a valuable initial insight into the links between the structures and processes of care and the clinical outcomes of people with diabetic foot ulcers in England and Wales.

Key findings

Audit findings can be grouped by the three key questions posed at audit inception: Structures Survey: are the nationally recommended care structures in place for the management of diabetic foot disease?

The current NICE guidelines recommend that commissioners and service providers ensure that there are robust protocols and clear local pathways for the continued and integrated care of people with diabetic foot disease across all settings. It is therefore necessary that:

Staff involved in the routine care of diabetes should be sufficiently skilled to undertake annual foot risk assessments and to refer those at increased risk of developing a diabetic foot ulcer to the foot protection service1.

A foot protection service is in existence for the assessment and continuing surveillance of those defined as being at increased risk in order to prevent diabetic foot ulcers, and to manage some of them in the community2.

A pathway for referral of people with diabetes with an active foot problem to a multidisciplinary foot care service or foot protection service within one working day and triaged within one further working day3.

The audit found that the structures needed for the provision of such services were not universal.

Almost 40 per cent of participating commissioning organisations were unable to give a definitive response (yes or no) to all of the NDFA Structures Survey questions.

More than 40 per cent of localities who could respond to all three questions did not have all three of the basic NICE recommended systems for preventing and managing diabetic foot disease.

1 NICE (2015) Diabetic foot problems: prevention and management. Recommendation 1.3.3-1.3.7

http://www.nice.org.uk/guidance/ng19 2 NICE (2015) Diabetic foot problems: prevention and management. Recommendation 1.2.1

www.nice.org.uk/guidance/ng19 3 Ibid.

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Processes: does the treatment of active diabetic foot disease comply with nationally recommended guidance?

1. Annual foot checks

The audit found that people with diabetes presenting with a foot ulcer are just as likely to have had a NICE recommended routine foot check4 in the preceding year as other people with diabetes (85 per cent in both groups).

At this stage it is not possible to conclude that the examination has no influence. Data quality concerns and variable referral pathways for people categorised as at an 'increased' or 'high risk' mean that further investigation is required.

2. People with a newly occurring foot ulcer should be referred and triaged within two days

The audit found that:

Almost 30 per cent of patients self-presented.

Two fifths of patients who did not self-present were not seen by the foot care service until two weeks or more after the first healthcare contact for their ulcer.

More than one in 10 of those who did not self-present were not seen for two months or more from the first healthcare contact.

The longer the delay before being seen by the diabetic foot care team, the more likely were the foot ulcers to be severe.

Outcomes: are the outcomes of diabetic foot disease optimised?

The audit found that:

One half of all patients were ulcer free at 12 weeks from first expert assessment.

Patients who self-presented or who were seen by the specialist foot care service within two weeks of first assessment by another healthcare professional had higher rates of ulcer healing than those seen later.

Patients presenting with more severe ulcers were almost twice as likely not to be ulcer free at 12 weeks after first expert assessment.

4 NICE (2015) Diabetic foot problems: prevention and management. Recommendation 1.4.2

http://www.nice.org.uk/guidance/ng19

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Recommendations The following recommendations are made as a result of the findings of the audit.

Recommendations for people with diabetes

People with diabetes should ensure that they have their feet checked at least once a year by a professional.

People with diabetes should seek professional advice as soon as they notice any problems with their feet.

Recommendations for healthcare professionals

All healthcare professionals should be aware of the need for prompt expert assessment of newly occurring foot ulcers in people with diabetes and should know how this assessment can be arranged.

Recommendations for commissioners

Commissioners should ensure that NICE recommended diabetic foot care teams and pathways are in place.

Commissioners should encourage all foot care services to register and submit details on as many as possible of their foot ulcer cases to the NDFA

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Introduction

Background The National Diabetes Foot Care Audit (NDFA) is part of the National Diabetes Audit programme (NDA).The NDA is commissioned by the Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP) following advice to the Department of Health from the National Advisory Group on Clinical Audit and Enquiries (NAGCAE). The NDA is delivered by the Health and Social Care Information Centre (HSCIC), in partnership with Diabetes UK and the National Cardiovascular Intelligence Network (part of Public Health England).

Foot ulceration is common in people with diabetes. Around 10 per cent of people with diabetes will have a diabetic foot ulcer at some point in their lives5 and the cost to the NHS is estimated at around £650 million (or £1 in every £150 the NHS spends)6.

In this context, the NDFA has been designed to deliver a reliable, low burden measurement system for diabetic foot disease. The measurements include the basic structure of care services, the management of each person presenting with active disease of the foot and the outcomes.

This report is the first annual report from a continuous audit of diabetic foot disease in England and Wales. All organisations that provide a diabetic foot ulcer treatment service are eligible for inclusion in the audit.

The audit is a measurement system to support improvement in the quality of care of foot ulcers in people with diabetes and seeks to address three key questions:

Structures: are the nationally recommended care structures in place for the management of diabetic foot disease?

Processes: does the treatment of active diabetic foot disease comply with nationally recommended guidance?

Outcomes: are the outcomes of diabetic foot disease optimised?

The report will be of importance to the public, especially to people with diabetes, to health planners and policy makers, as well as acute trusts, CCGs, LHBs, Strategic Clinical Networks (SCNs), primary care teams, and specialist diabetes and foot care services. The results of the audit will be used to monitor the quality of care provided for diabetic foot disease against NICE guidance7.

The audit of the structure of care (NDFA Structures Survey) was conducted in October and November 2015 when all CCGs and LHBs responsible for the provision of foot care services were asked to complete a short survey consisting of three questions.

The audit of processes and outcomes is centred on people with diabetes who were first assessed by a specialist foot care team between 14 July 2014 and 10 April 2015. The baseline characteristics and outcomes after 12 week follow up were recorded. Data on outcomes at 24 weeks follow up are also recorded in the audit, and will be included in the next annual report.

5 NICE Guidelines: Diabetic foot problems: prevention and management; August 2015;

http://www.nice.org.uk/guidance/ng19 6 Kerr M (2012) Foot Care for people with diabetes: the economic Case for Change. NHS Diabetes and Kidney

Care. http://www.diabetes.org.uk/Documents/nhs-diabetes/footcare/footcare-for-people-with-diabetes.pdf 7 NICE Guidelines: Diabetic foot problems: prevention and management; August 2015;

http://www.nice.org.uk/guidance/ng19

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Full data on outcomes, including hospital admissions and amputation, is dependent on Hospital Episode Statistics (HES) and the Patient Episode Database for Wales (PEDW) and the details covering the audit period will not be available until late 2016. The result is that data on these outcomes could not be included in this first report but will be included in the next annual report.

Data collection The majority of the data for the NDFA is collected and submitted by foot care teams. Each participating team obtains explicit consent from each person prior to data being collected. If the person does not consent, their information is not collected.

Some data items are obtained by linking the NDFA audit data to the NDA. Linkage to HES and PEDW will be undertaken in subsequent years.

Data for the NDFA Structures Survey is collected from CCGs and LHBs. The deadline for submissions for inclusion in this report was 4 December 2015.

Participation 97 providers of foot care services submitted data for the first audit report on behalf of 129 specialist foot care teams. 5,015 patients with 5,215 first attendances for foot ulcer assessment were reported.

There is no definitive list of units eligible for the NDFA, so it is not possible to accurately assess provider participation. 60 per cent of CCGs and LHBs participated in the NDFA Structures Survey.

97 service providers

•Each provider (NHS Trust or LHB) was responsible for at least one foot care service. Some providers operated multiple services.

129 foot care services

•Each foot care service reported at least one initial patient assessment for foot ulcer to the audit.

5,215 attendances

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NDFA patient pathway from development of ulcer

The flowchart below (Figure 1) gives an overview of the patient pathway for diabetic foot ulcer patients from first presentation to a health professional until the 12 week assessment by the specialist foot care team. The related NDFA data items are shown on the left hand side of diagram.

Figure 1: Patient pathway from development of ulcer to 12 week assessment

* To be published in the 2017 NDFA report

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Participation – Results and Findings

NDFA Structures Survey Commissioners of care for diabetic foot disease were asked to complete answers online to three questions on the NICE specified structures of care provided in their area (see Appendix 2).

The audit received answers from 125 CCGs in England (59.8 per cent), four LHBs in Wales (57.1 per cent) and another four commissioning hubs representing unknown CCGs.

NDFA processes and outcomes collection All organisations that provide a diabetic foot ulcer treatment service are eligible for inclusion in the NDFA processes and outcomes collection. 129 foot care services submitted data for the first audit report representing 97 service providers (see Table 1). Additional foot care services registered with the audit but they did not submit data prior to the collection deadline (31 July 2015). Due to the varied nature of specialist foot care services and how these are commissioned and run, it is difficult to determine the exact percentage of eligible providers that have registered or made a submission.

Table 1: Registration and participation in the audit by country, England and Wales, 2014-2015

Foot care services* Service providers^

Country Registered# Participated Registered

# Participated

England 202 112 119 90

Wales 19 17 7 7

England and Wales 221 129 126 97

* Individual foot care services that treat people with diabetic foot ulcers. ^ NHS trusts in England and local health boards (LHB) in Wales. # Registered to submit data to the NDFA.

A full list of participating NHS trusts, LHBs, independent healthcare providers (IHPs) and their foot care services can be found in Appendix 3. A map showing participating service providers by the distribution of their foot care services is provided in Appendix 4.

Jargon buster Foot care services are individual specialist services that treat people with diabetic foot ulcers. This

includes community and hospital based organisations, as well as any GP practice that provides a specialist diabetic foot treatment service.

Service providers are the foot care service’s parent organisation. This is typically an NHS trust in

England, a local health board (LHB) in Wales or an independent healthcare provider (IHP). A single service provider may be responsible for multiple foot care services.

Commissioners decide what health services are needed and ensure that they are provided. 209 Clinical Commissioning Groups (CCGs) in England and seven local health boards (LHBs) in Wales

are responsible for commissioning healthcare services.

Recommendation

Audit recommendation: All foot care services are encouraged to register and make submissions to the audit.

Key finding and recommendation

Audit finding: About 60 per cent of CCGs and LHBs participated in the NDFA Structures Survey.

Audit recommendation: All CCGs and LHBs are encouraged to make submissions to the NDFA Structures Survey.

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NDFA submissions

The audit collected data when the patient first presented to the specialist service for a new episode of diabetic foot ulceration. This might be their first encounter with the foot care service or a later attendance after a period of having been ulcer free.

5,215 attendances between 14 July 2014 and 10 April 2015 were recorded in the audit, for 5,015 patients. The large majority of patients (96.3 per cent) had only one episode of foot ulceration recorded during the audit period, with the remainder (3.7 per cent) having two or three ulcer episodes reported.

Per service provider, the mean number of ulcers for which data were recorded was 53.8, with a median of 40. The overall distribution of such ulcers is shown in the box and whisker plot below (Figure 2), where the middle 50 per cent, or interquartile range, is represented by the box. More than a quarter of service providers recorded fewer than 20 attendances each, whilst the 21 largest submitters were responsible for over half of all attendances in the audit. As this was the first year of the NDFA, it should be noted that providers began participating throughout the audit period, and as such, the duration of participation could vary by up to nine months between providers.

Figure 2: Distribution of ulcer numbers submitted by service providers, England and Wales, 2014-2015

The geographic distribution of audit submissions is shown in Table 2 below. England is split into Strategic Clinical Networks (SCN) and Wales is reported as a whole. The area with the highest number of submissions (South West SCN with 700) reported nine times as many ulcers as the lowest submitting area (Thames Valley SCN).

Table 2: Participation in the audit by country/network, England and Wales, 2014-2015

Country / Network^ Number of service

providers submitting data to the audit

Number of foot care services submitting

data to the audit

Number of ulcers

Cheshire and Merseyside 3 3 169

East Midlands 8 8 562

East of England 11 15 486

Greater Manchester, Lancashire and South Cumbria

9 15 573

London 10 12 439

Northern England 8 11 464

South East Coast 11 11 317

South West 9 10 700

Thames Valley 2 3 77

Wessex 2 2 118

West Midlands 7 8 342

Yorkshire and the Humber 10 14 638

England 90 112 4,885

Wales 7 17 330

England and Wales 97 129 5,215 ^ Service providers and associated foot care services in England are mapped to Strategic Clinical Networks (SCNs)

using the service provider’s postcode.

0 50 100 150 200 250 300

Service providers(n=97; median=40)

Number of ulcers

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Case ascertainment

The annual incidence of diabetic foot ulceration has been estimated at 2.2 per cent8, which suggests that NDFA case ascertainment in the first nine months from the launch was approximately 10 per cent9.

Linkage to the core National Diabetes Audit

By linking to the core National Diabetes Audit (NDA), the NDFA is able to include and analyse NDA data without placing an additional collection burden on service providers. NDFA patients were linked to the latest three NDA core cohorts (2012-13, 2013-14 and 2014-15) using NHS number, with the latest data items used for the NDFA analysis. A full list of the NDA data items included is provided in Appendix 6.

In total, 4,522 (90.2 per cent) NDFA patients could be linked to the NDA, leaving 493 (9.8 per cent) that could not be linked10.

Table 3: Number of new ulcer presentations included in the audit, England and Wales, 2014-2015

All NDFA

i NDFA

i linked to NDA

ii data

Number Number Per cent

People 5,015 4,522 90.2

Ulcers 5,215 4,699 90.1 i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

8 Abbott CA, Carrington AL, Ashe H, et al. The North-West Diabetes Foot Care Study: incidence of, and risk

factors for, new diabetic foot ulceration in a community-based cohort. Diabet Med 2002; 19: 377–84. 9 Using diabetes prevalence figures collected by the Quality and Outcomes Framework (QOF) and published

on https://www.diabetes.org.uk/About_us/What-we-say/Statistics/2015-as-published-2016/ (accessed 21 January 2016), then adjusted for the 9 month NDFA collection period. 10

Although the NDA is a national collection, coverage is not complete, standing at 70.7 per cent for 2012-13, 57.1 per cent for 2013-14 and 57.3 per cent for 2014-15. Consequently not all NDFA patients could be linked to the NDA.

Key finding

Audit finding: 90 per cent of individuals recorded with a foot ulcer on the NDFA had core data registered on the National Diabetes Audit.

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Characteristics of people with diabetes presenting with foot ulcers – Results and Findings

Linkage to NDA was used to investigate differences between people in the NDFA cohort and the diabetes population as a whole.

In comparison to the wider population of people with diabetes, the audit found that people presenting with a foot ulcer are:

More likely to have Type 1 diabetes (13.0 per cent in NDFA compared to 8.6 per cent in NDA).

More likely to be male (69.6 per cent compared to 55.7 per cent).

Older on average (67.3 years compared to 63.6 years), particularly those with Type 1 diabetes (55.7 years compared to 42.9 years).

Likely to have had diabetes for longer (an average of 15.0 years compared to 8.6 years), particularly those with Type 1 diabetes (26.5 years compared to 17.6 years).

Less likely to be from an Asian or black ethnic background (For Type 2 diabetes: White NDFA 69.0 per cent, NDA 60.8 per cent; Asian NDFA 2.8 per cent, NDA 9.9 per cent; Black NDFA 2.7 per cent, NDA 4.2 per cent).

More likely to be from the most deprived fifth of the population (26 per cent compared to 22.9 per cent).

Slightly heavier on average (average BMI of 31.1 kg/m2 compared to 30.8 kg/m2),

More likely to be a current or past smoker where diabetes is Type 1 (43.5 per cent compared to 33.1 per cent).

Less likely to have achieved their NICE recommended treatment targets for HbA1c during the previous year (44.1 per cent compared to 64.1 per cent).

Further details on the above findings can be found in Appendix 9.

Perspectives from people with diabetes

The importance of early expert assessment:

“Having regular foot checks since diagnosis of Type 1 diabetes 44 years ago has meant that any problems with my feet have been noticed early and not led to further problems. In recent years when calluses have formed under my feet, causing my feet to become very sensitive, it has been really helpful to get expert advice on how to care for this condition”.

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Structure - Results and Findings

Service provision and commissioners The NDFA Structures Survey asked commissioners of care for diabetic foot disease (CCGs in England and LHBs in Wales) whether the following NICE recommended structures of care were in place in their area:

A training scheme ensuring healthcare professionals have the necessary competence to undertake routine foot examinations11 during annual diabetes reviews.

An established referral pathway for patients identified as higher risk during annual foot examination into a designated foot protection service12.

An established referral pathway for patients with new, deteriorating or recurrent foot disease to expert assessment within, when necessary, 24 hours13.

Caution is advised when interpreting these results; less than 60 per cent of commissioners participated (see Participation on page 15), so this is not a comprehensive national picture. The proportion of ‘don’t know’, blank and conflicting responses also makes interpretation difficult. This may suggest confusion amongst commissioners in relation to services that manage diabetic foot disease. 51 of the 133 participating organisations (38.3 per cent) were unable to give a definitive response (yes or no) to one or more of the NDFA Structures Survey questions.

The results of the NDFA Structures Survey are summarised in Table 4 below.

Table 4: Number of CCG and LHB responses to the NDFA Structures Survey

Foot care service

Training for routine diabetic foot examinations

Foot protection service Pathway

Pathway for assessment within 24 hrs

Service provided? Number Per cent Number Per cent Number Per cent

Yes 76 57.1 103 77.4 72 54.1

No 25 18.8 13 9.8 33 24.8

Don’t know 27 20.3 8 6.0 12 9.0

Conflicting responses 5 3.8 5 3.8 2 1.5

No response 0 0.0 4 3.0 14 10.5

Total 133 133 133

82 of the 133 (61.7 per cent) participating organisations were able to give definitive responses (yes or no) for each of the three questions. Table 4 shows the number and proportion of the 82 organisations answering ‘yes’ to having 0, 1, 2 or 3 of the NICE recommended diabetic foot care services.

11

NICE (2015) Diabetic foot problems: prevention and management: Implementation, http://www.nice.org.uk/guidance/ng19/chapter/Implementation-getting-started 1.3.3-1.3.7 12

NICE (2015) Diabetic foot problems: prevention and management, www.nice.org.uk/guidance/ng19 1.2.1 13

Ibid 1.4.1

Key finding and recommendation

Audit finding: Almost 40 per cent of participating organisations were unable to give a definitive response (yes or no) to one or more of the NDFA Structures Survey questions.

Audit recommendation: Commissioners should improve their understanding of locally commissioned services that manage diabetic foot disease.

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Table 5: Foot care service provision among responders answering all three questions

Answered ‘Yes’ to …

Total 0 questions 1 question 2 questions 3 questions

Number Per cent Number Per cent Number Per cent Number Per cent

Organisations 4 4.9 8 9.8 25 30.5 45 54.9 82

Table 5 shows that only 45 (54.9 per cent) of the 82 complete responders had all three pathways in place.

Figure 14 in Appendix 5 shows the geographical distribution of responses from the 82 commissioners which answered each of the NDFA Structures Survey questions, with the locations of service providers that participated in the Audit highlighted in Figure 13 in Appendix 4.

Processes – Results and Findings

Foot risk assessment Current NICE guidance is to undertake foot assessments annually, with more frequent assessments for those assessed as being at a moderate or high risk of developing a diabetic foot problem14.

Linkage to NDA was used to investigate the proportion of people in the NDFA cohort that had undergone a foot assessment in the preceding NDA collection period (January 2013 to March 2014)15.

Table 6 shows that people with diabetes presenting with a foot ulcer are just as likely to have had a NICE recommended annual foot check in the preceding year as other people with diabetes (84.9 per cent in both groups).

Table 6: Foot risk assessment recorded in the NDA, January 2013 – March 2014, England and Wales, NDFA patients first seen in 2014-2015

Annual foot risk assessment undertaken

All diabetes (N=2,683)

Type 1 (N=374)

Type 2 and other (N=2,309)

NDFAi

NDAii

NDFAi

NDAii

NDFAi

NDAii

Number Per cent Per cent Number Per cent Per cent Number Per cent Per cent

2,277 84.9 84.9 308 82.4 70.7 1,969 85.3 86.2

^ Where the values in a row in the table are bolded, the difference between the comparable NDFA and NDA percentages are statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

14

NICE recommended care processes http://pathways.nice.org.uk/pathways/foot-care-for-people-with-diabetes. 15

The January 2013 to March 2014 NDA cohort was used to ensure that NDA recorded foot reviews took place prior to the NDFA attendance

Key finding and recommendation

Audit finding: Of the sites that responded definitively to the NDFA Structures Survey, more than 40 per cent of fully responding localities do not have all three of the basic NICE recommended systems for preventing and managing diabetic foot disease.

Audit recommendation: Commissioners should ensure that NICE recommended diabetic foot care teams and pathways are in place.

Key finding and recommendation

Key finding: People with diabetes presenting with a foot ulcer are just as likely as to have had a NICE recommended routine foot check in the preceding year as other people with diabetes (85 per cent in both groups).

Audit recommendation: People with diabetes should ensure that they have their feet checked at least once a year by a professional.

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Ulcer characteristics and time to first assessment

Index and multiple ulcers

As part of the data collection for the NDFA, details of the patient’s index (most severe) ulcer were recorded. Patients could present with a single index ulcer or with multiple ulcers of equal severity on one or both feet.

Table 7 shows that the majority of patients (88.8 per cent) presented with a single index ulcer. This was almost eight times as many as those who presented with multiple foot ulcers (11.2 per cent).

Table 7: Location of index (most severe) ulcer, England and Wales, 2014-2015†^

Ulcer type

All diabetes

(N=5,215)

Type 1

(N=610) †

Type 2 and other

(N=4,089) †

Number Per cent Number Per cent Number Per cent

Index ulcer (single foot) 4,632 88.8 539 88.4 3,643 89.1

Multiple ulcers (either foot)* 583 11.2 71 11.6 446 10.9

* Includes where index ulcer recorded on both right and left foot. ^ Where the percentages in a row in the table are bolded, the difference between the Type 1 and Type 2

percentages is statistically significant ( <0.05). † Not all ulcers could be matched to a diabetes type, so the sum of Type 1 and Type 2 ulcers does not equal the total

for all diabetes.

Charcot foot disease

Information on Charcot foot disease was collected to examine the impact of Charcot on the healing of associated ulcers. The returned data is summarised in Table 8 below.

Table 8: Current or previous Charcot foot disease, England and Wales, 2014-2015†^

Charcot status

All diabetes

(N=5,215)

Type 1

(N=610) †

Type 2 and other

(N=4,089) †

Number Per cent Number Per cent Number Per cent

No Charcot 3,957 75.9 437 71.6 3,098 75.8

Possible Charcot foot 80 1.5 18 3.0 56 1.4

Single ulcer

Active Charcot foot on index ulcer foot

43 0.8 8 1.3 34 0.8

Inactive Charcot foot on index ulcer foot

152 2.9 29 4.8 107 2.6

Active Charcot foot on other foot only

14 0.3 1 0.2 12 0.3

Inactive Charcot foot on other foot only

46 0.9 13 2.1 28 0.7

Multiple ulcers

Active Charcot foot, involving one or both feet

5 0.1 0 0.0 5 0.1

Inactive Charcot foot only, involving one or both feet

23 0.4 3 0.5 19 0.5

Not recorded 895 17.2 101 16.6 730 17.9

^ Where the percentages in a row in the table are bolded, the difference between the Type 1 and Type 2

percentages is statistically significant ( <0.05). † Not all ulcers could be matched to a diabetes type, so the sum of Type 1 and Type 2 ulcers does not equal the total

for all diabetes.

22

Table 8 shows that approximately 1 in 14 patients (7.0 per cent) presenting with a diabetic foot ulcer have Charcot neuroarthropathy, with a slightly higher prevalence amongst people with Type 1 diabetes. It also suggests that the chance of the presenting ulcer being on the Charcot foot is around three times greater than it being on the non-Charcot foot.

More generally, the audit found that only a small percentage of all ulcer cases had active (0.8 per cent) or inactive (2.9 per cent) Charcot foot disease present on their index foot. As only a few foot ulcer patients are affected, the usefulness of continuing to collect Charcot data will be considered for future foot care audit collections.

Ulcer severity

The audit recorded the severity of the patient’s index ulcer using the SINBAD scoring system (see Appendix 7). An ulcer can score between 0 (least severe) and 6 (most severe). Ulcers with a SINBAD score of 3 or above are considered to be severe.

Table 9 below shows the number and proportion of ulcers that had each of the six elements of the SINBAD severity score16. More than 80 per cent of ulcerated feet had loss of protective sensation (neuropathy), while the other elements affected between one fifth and one half of NDFA patients.

Table 9: SINBAD score for ulcers, England and Wales, 2014-2015†^

SINBAD element

All diabetes (N=5,215)

Type 1

(N=610) †

Type 2 and other

(N=4,089)†

Number Per cent Number Per cent Number Per cent

Site 948 18.2 128 21.0 730 17.9

Ischaemia 1,882 36.1 180 29.5 1,512 37.0

Neuropathy 4,309 82.6 534 87.5 3,344 81.8

Bacterial infection 2,272 43.6 297 48.7 1,741 42.6

Area 2,538 48.7 332 54.4 1,947 47.6

Depth 924 17.7 107 17.5 716 17.5

SINBAD score >=3 * 2,411 46.2 313 51.3 1,842 45.0 † Not all ulcers could be matched to a diabetes type, so the sum of Type 1 and Type 2 ulcers does not equal all

diabetes attendances. ^ Where the percentages in a row in the table are bolded, the difference between the Type 1 and Type 2

percentages is statistically significant ( <0.05). * An ulcer with a SINBAD score of 3 or above is classed as severe.

Table 9 also shows that patients with Type 1 diabetes were more likely to present with more severe ulcers than those with Type 2 diabetes (51.3 per cent compared to 45.0 per cent). When broken down by the individual elements, patients with Type 1 diabetes had higher rates of Neuropathy, Bacterial infection and larger surface areas (Area), although rates of Ischaemia are lower.

Figure 3 below shows the distribution of SINBAD scores in foot ulcer patients. Only 236 (4.5 per cent) of the 5,215 ulcers had the least severe SINBAD score of 0. 46.2 per cent of ulcers were in the severe category, with a SINBAD score of 3 or more, with just 1.1 per cent assessed at the maximum severity with a score of 6.

16

Loss of protective sensation (Neuropathy), impaired circulation (Ischaemia) and penetration of the hind-foot (Site) are considered potential indicators of delayed healing of the ulcer, rather than measures of severity.

Key finding

Audit finding: The proportion of new foot ulcers that are severe is higher in Type1 than in Type 2 diabetes patients.

Key finding

Audit finding: Few patients present with a foot ulcer and concurrent Charcot foot disease on the same foot.

23

Figure 3: Distribution of overall SINBAD scores for foot ulcers, England and Wales, 2014-2015

Time to first assessment

The audit collected data on the interval between first presentation to a health professional and first assessment by the multi-disciplinary foot team. Current NICE guidance recommends that people with diabetes with an active foot problem should be referred to the multidisciplinary foot care service or foot protection service within one working day and triaged within one further working day17. The audit results are summarised in Figure 4 below.

Figure 4: Interval between first presentation to a health professional and first assessment by the multi-disciplinary foot team, England and Wales, 2014-2015

Figure 4 shows that almost one third of ulcer cases were self-presented (29.1 per cent). Of the remainder, only a minority (14.4 per cent of all cases) were seen within the NICE standard of two days. The delay for many was very long. If self-presenting patients are excluded, almost two fifths of patients (39.2 per cent) were not seen by the foot care service until two weeks after the first healthcare contact for their ulcer.

17

NICE guidelines – Diabetic foot problems: prevention and management. Recommendation 1.4.2 http://www.nice.org.uk/guidance/ng19

0 1 2 3 4 5 6

n 236 1139 1429 1210 817 326 58

(%) 4.5 21.8 27.4 23.2 15.7 6.3 1.1

0.0

5.0

10.0

15.0

20.0

25.0

30.0%

of

pat

ien

ts

7.7

20.1

28.7

14.4

29.1

0 5 10 15 20 25 30 35

> 2 months

14 days - 2 months

3-13 days

<= 2 days

Self presenting

Percentage of attendances

Key finding and recommendation

Audit finding: Almost 30 per cent of patients self-

presented.

Audit finding: Almost two fifths of patients who did not self-present were not seen by the foot care service until two weeks after the first healthcare contact for their ulcer.

Audit recommendation: All healthcare professionals should be aware of the need for prompt expert assessment of newly occurring foot ulcers in people with diabetes and should know how this assessment can be arranged.

24

Time to first assessment and ulcer severity

Table 10 shows that people who presented with severe ulcers are more likely to wait for two or more weeks for assessment by an expert than those with less severe ulcers (32.9 per cent compared to 23.5 per cent). The results also show that a lower proportion of severe ulcers are self-presented (21.3 per cent compared to 35.7 per cent).

Table 10: Interval between first presentation to a health professional and first assessment by the multi-disciplinary foot team by SINBAD score, England and Wales, 2014-2015^

Time to presentation

SINBAD < 3 (N=2,804)

SINBAD >=3 (N=2,411)

Number Per cent Number Per cent

Self-presenting 1,002 35.7 514 21.3

<= 2 days 380 13.6 370 15.3

3-13 days 764 27.2 734 30.4

14 days - 2 months 496 17.7 553 22.9

> 2 months 162 5.8 240 10.0

^ Less severe ulcers have a SINBAD score <3. Severe ulcers have a SINBAD score >=3. Where the percentages in a row in the table are bolded, the difference between SINBAD groups is statistically

significant ( <0.05).

Figure 5 shows that the proportion of severe ulcers tends to increase amongst patients with a longer interval to first presentation (from 33.9 per cent where self-presenting compared to 59.7 per cent with a wait of two or more months). The results also show that a smaller proportion of ulcers are graded severe in people who are self-presenting (33.9 per cent compared to 49.0 per cent and above for all other categories).

Figure 5: Interval to first presentation by SINBAD score, England and Wales, 2014-2015^

^ Less severe ulcers have a SINBAD score <3. Severe ulcers have a SINBAD score >=3.

40.3

47.3

51.0

50.7

66.1

59.7

52.7

49.0

49.3

33.9

0 10 20 30 40 50 60 70 80 90 100

> 2 months

14 days - 2 months

3-13 days

<= 2 days

Self presenting

SINBAD Score prevalence of patients within interval group (%)

SINBAD < 3

SINBAD >= 3

Key finding

Audit finding: People who are first seen by the diabetic foot care team after 2 or more months are more likely to present with severe foot ulcers.

25

Foot protection service referral pathway and ulcer severity

Table 11 below shows the relationship between ulcer severity (SINBAD) score at presentation and commissioning organisations with or without a pathway for referral to a foot protection service. To undertake this analysis, NDFA patients were assigned to their latest available responsible CCG or LHB in the NDA and then linked to that organisation’s Structures Survey response. As only 2,629 of the 5,215 NDFA attendances (50.4 per cent) could be linked to a participating CCG or LHB with a definitive response to this question (yes or no), caution is advised when interpreting this data.

Table 11: SINBAD score† band for patients, linked to organisations with / without a pathway for referral to a foot protection service^

SINBAD score < 3 SINBAD >=3 Total

Organisation response: Number Per cent Number Per cent Number

Yes 1,451 56.4 1,122 43.6 2,573

No 26 46.4 30 53.6 56

^ Less severe ulcers have a SINBAD score <3. Severe ulcers have a SINBAD score >=3. Where the values in a column in the table are bolded, the difference between the two percentages is statistically significant (p <0.05). †A lower SINBAD score has been shown to be associated with a more favourable outcome

18.

Of all patients linked to a commissioner with a definite response, 2,573 (97.9 per cent) were associated with an organisation with a referral pathway to a foot protection service, leaving just 56 patients (2.1 per cent) treated by an organisation that did not provide this service. The small sample size of the latter group makes comparison problematic, and no significant differences can be observed.

18

Ince P, Abbas ZG, Lutale JK, et al. Use of the SINBAD classification system and score in comparing outcome of foot ulcer management on three continents. Diabetes Care. 2008;31:964-7.

Perspectives from people with diabetes

The importance of early treatment:

“I had the fourth toe on my left foot amputated last year. I had been being seen by a local chiropodist who referred me to my GP when he noticed potential infection in the foot. I got an appointment almost immediately and the GP prescribed some antibiotics and arranged another appointment at the hospital with a specialist in two weeks. I had surgery very quickly which was successful. I now see a specialist team for diabetes foot care once a week.

They have been able to spot potentially dangerous ulcers early and treat them effectively, also giving me specialist shoes on prescription to prevent ulcers forming. This has likely prevented further problems. The podiatry services in my local area are very good, kind and caring, especially the specialist team which have just been recently set up - previously podiatry services were very poor”.

26

Audit Outcomes – Being ‘Ulcer Free’ at 12 Weeks – Results and Findings This section looks at whether or not the patient was alive and ulcer free at 12 weeks following their first foot ulcer assessment by the treatment team19. Being ‘ulcer free’ includes those patients who have had surgery (including major and minor amputation), provided all wounds have healed. The audit collected the patient status at 12 weeks following first expert assessment20. The results are summarised in Table 12 below. Table 12: Outcome at 12 weeks after first expert assessment, England and Wales, 2014-2015†^

12 week outcome

All diabetes (N=5,215)

Type 1 (N=610)

†

Type 2 and other (N=4,089)

†

Number Per cent* Number Per cent* Number Per cent*

No foot ulcer 2,302 49.2 260 46.9 1,799 49.1

Foot ulcer present 2,373 50.8 294 53.1 1,864 50.9

Deceased 119 6 96

Unknown outcome 421 50 330

^ Where the percentages in a row in the table are bolded, the difference between the Type 1 and Type 2 percentages is statistically significant (p <0.05). † Not all ulcers could be matched to a diabetes type, so the sum of Type 1 and Type 2 ulcers does not equal the total

for all diabetes. * Per cent of cases where ulcer status is recorded for those alive at 12 weeks.

8.1 per cent of ulcers had no 12 week status recorded. In a further 2.3 per cent of cases the patient had died before the 12 week assessment was undertaken. This very high short term mortality is not inconsistent with the known high one year and five year mortality rates in people with diabetic foot ulcers21, although the number of patients in the NDFA to date, are insufficient to make this a reliable 12 week mortality estimate.

Of the remainder, 12 week outcomes were evenly split between patients that were ulcer free at 12 weeks (49.2 per cent) and those that still had foot ulceration (50.8 per cent). There was no difference in outcomes between patients with Type 1 and Type 2 diabetes.

19 The interval between the cohort end date (10 April 2015) and the submission deadline (31 July 2015) was

insufficient for outcomes at 24 weeks to be reported. Outcomes at 24 weeks will form part of future NDFA reports. 20

’Ulcer’ applies to any persisting wound including those following surgical treatment (i.e. amputation or surgical revascularisation). Being ulcer free will include those who have undergone surgery but in whom all wounds have healed. 21

Brownrigg JR et al. The association of ulceration of the foot with cardiovascular and all-cause mortality in patients with diabetes: a meta-analysis. Diabetologia 2012; 55: 2906-12.

Key finding

Audit finding: One half of patients were ulcer

free at the 12 week assessment.

27

Being ulcer free at 12 weeks and referral pathway for assessment within 24 hours Table 13 below shows the relationship between observed 12 week healing outcomes and whether commissioning organisations reported having a pathway for referral for assessment within 24 hours. Only 38.6 per cent of NDFA cases were from localities where commissioners had returned answers to this structure survey question, so caution should be advised when interpreting this table. Table 13: Observed 12 week healing outcome for patients, linked to organisations with / without a pathway for referral for assessment within 24 hours

Active ulcer No ulcer Total

Organisation response Number Per cent Number Per cent Number

Yes 792 53.5 688 46.5 1,480

No 295 55.6 236 44.4 531

^Where the values in a column in the table are bolded, the difference between the two percentages is statistically significant (p <0.05).

The proportion of patient attendances with active or no ulcer at 12 weeks was similar for patients from commissioners with a referral pathway for urgent assessment as for those from commissioners without such a referral pathway.

Being ulcer free at 12 weeks and time to first assessment Figure 6 shows the proportion of ulcer free 12 week outcomes split by time to first assessment by a specialist foot care service. Figure 6: Time to first specialist assessment and outcomes at 12 weeks, England and Wales, 2014-2015†^

† Only cases with a 12 week ulcer status recorded have been included in this analysis.

^ Where the percentages to the right of the bar are bolded, the difference between the interval group and the

comparison group (<= 2 days) is statistically significant ( <0.05).

56.3

49.3

50.0

43.2

34.3

0.0 10.0 20.0 30.0 40.0 50.0 60.0

Self presenting

<= 2 days

3-13 days

14 days - 2 months

> 2 months

Prevalence of ulcer free cases at 12 weeks (%)

Tim

e t

o f

irst

ass

ess

me

nt

28

Figure 6 shows that the ulcer healing rate decreases as the interval to first presentation lengthens. There is a significant difference between the healing rate of those that were seen within two weeks (49.8 per cent for <=2 days and 3-13 days combined) compared to that of both those who were not seen for longer than two months (34.3 per cent), and those who were seen between 14 days and two months (43.2 per cent).

There was no observable difference between the healing rates of those that were seen within two days (49.3 per cent) and those seen between three and 13 days after presentation (50.0 per cent).

Being ulcer free at 12 weeks and ulcer severity Figure 7 shows the proportion of ulcer free outcomes for ulcers with or without each SINBAD element. Figure 7: SINBAD score for the index ulcer and ulcer free outcomes at 12 weeks after first expert assessment, England and Wales, 2014-2015†^

† Only cases with a 12 week ulcer status recorded have been included in this analysis.

^ Where the percentages to the right of the bar are emboldened, the difference between the healing rates where the

SINBAD element is or isn’t present, is statistically significant ( <0.05).

* An ulcer with a SINBAD score of three or above is classed as severe.

51.2

54.7

58.3

55.9

59.9

52.9

40.0

39.0

47.3

40.5

37.6

31.6

0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0

Site

Ischaemia

Neuropathy

BacterialInfection

Area

Depth

% ulcer free at 12 weeks

SIN

BA

D E

lem

en

t

No

Yes

60.3

36.0

0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0

Severe ulcer*

NoYes

Key finding and recommendations

Audit finding: Patients seen by the specialist foot care service within two weeks of first assessment by a professional have higher rates of ulcer healing than those seen later.

Audit recommendation: Patients are encouraged to seek professional advice as soon as they notice any problems with their feet.

Audit recommendation: All healthcare professionals should be aware of the need for prompt expert assessment of newly occurring foot ulcers in people with diabetes and should know how this assessment can be arranged.

29

Figure 7 shows that every element of the SINBAD assessment is associated with a reduced likelihood of healing at 12 weeks, although we do not know how many of the associations are independent. Area greater than 1cm2 (Area) and depth to tendon or bone (Depth) were the two elements most predictive of non-healing at 12 weeks. After 12 weeks, patients that presented with more severe ulcers (SINBAD score >= 3) are almost twice as likely still to have foot ulcers as patients with less severe ulcers (60.3 per cent compared to 36.0 per cent).

Key findings

Audit finding: Patients presenting with more severe ulcer cases are almost twice as likely not to be ulcer free at 12 weeks after first expert assessment.

Audit finding: Every SINBAD element is associated with reduced healing at 12 weeks.

Perspectives from people with diabetes

The importance of early treatment:

“I am fortunate to live in an area that has wonderful secondary care diabetes facilities. So when I had problems in 2002 resulting in amputations over eight years the Multi-Disciplinary Team were on hand to give me excellent expert medical care across many disciplines with input from me. This has resulted in me only losing five toes rather than a foot. I continue to have regular checks and am now stable without any further surgery since 2010. The outcome could have been a lot different without swift intervention”.

30

Being ulcer free at 12 weeks and variation between providers

There is considerable variation in the observed 12 week healing rates between different service providers (see Figures 8 and 9). For example, at SCN level, the 12 week healing rate for severe ulcers (SINBAD score >= 3) ranged from less than one fifth (19.7 per cent) in Cheshire and Merseyside to almost one half (47.8 per cent) in the South West.

Caution should be applied when reviewing these figures: results have not been case-mix adjusted (although factors including age have not been observed to explain the outcome, see discussion on page 33), case ascertainment is low (approximately 10 per cent) and there are regional variations in the quality and quantity of data supplied to the NDFA.

Figure 8: Observed 12 week healing rate for less severe ulcers (SINBAD score <3), by strategic clinical network, England and Wales, 2014-2015^

^ The number of participating service providers within the SCN is shown each bar.

Figure 9: Observed 12 week healing rate for severe ulcers (SINBAD score >=3), by strategic clinical network, England and Wales, 2014-2015^

^ The number of participating service providers within the SCN is shown each bar.

2

7

8 8

10

2

7 2

9

10

8 9

8

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

Wessex

Wale

s

Ea

st M

idla

nds

Ea

st of E

ngla

nd

So

uth

East C

oast

Cheshire a

nd

Me

rseysid

e

West M

idla

nds

Th

am

es V

alle

y

Yo

rksh

ire

an

d th

e H

um

be

r

London

Gre

ate

r M

ancheste

r,Lancs a

nd S

. C

um

bria

So

uth

West

Nort

he

rn E

ng

lan

d

% u

lcer

free a

t 12

weeks

England and Wales

2 8 2 2 9 7 11

11

8 9 9 7 9

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

Cheshire a

nd

Me

rseysid

e

Ea

st M

idla

nds

Wessex

Th

am

es V

alle

y

London

Wale

s

Ea

st of E

ngla

nd

So

uth

East C

oast

Nort

hern

En

gla

nd

Gre

ate

rM

ancheste

r,Lancs a

nd S

.…

Yo

rksh

ire a

nd th

e H

um

ber

West M

idla

nds

So

uth

West

% u

lcer

free a

t 12

weeks

England and Wales

31

Figure 10 below shows the variation in observed healing rates for individual service providers (NHS trusts, LHBs and IHPs). Caution is again advised when interpreting these figures, particularly due to the small numbers submitted by most service providers. Results have again been split by the severity of the ulcer.

Figure 10: Observed 12 week healing rates for service providers, split by ulcer severity, England and Wales, 2014-2015^

^ Less severe ulcers have a SINBAD score <3. Severe ulcers have a SINBAD score >=3.

The mean 12 week healing rate for service providers was 59.8 per cent for less severe ulcers and 35.2 per cent for severe ulcers. The medians for less severe and severe ulcers were 61.8 and 33.3 respectively. The overall distribution of healing rates is shown in the box and whisker plots below (Figures 11 and 12). The inter-quartile ranges of 48.5 to 71.9 per cent for less severe ulcers and 24.4 to 45.7 per cent for severe ulcers demonstrates considerable variation within the middle 50 per cent of service providers.

Figure 11: Range of observed healing rates for less severe ulcers by service providers, England and Wales, 2014-2015^

^ An ulcer with a SINBAD score of 3 or above is classed as severe.

Figure 12: Range of observed healing rates for severe ulcers by service providers, England and Wales, 2014-2015^

^ An ulcer with a SINBAD score of 3 or above is classed as severe.

0

5

10

15

20

25

0 -

10

10

-20

20

- 3

0

30

- 4

0

40

- 5

0

50

- 6

0

60

- 7

0

70

- 8

0

80

- 9

0

90

- 1

00

Nu

mb

er

of

serv

ice

pro

vid

ers

% ulcer free at 12 weeks

Less severeulcer

Severe ulcer

0 10 20 30 40 50 60 70 80 90 100

Service providers(n=63; median=61.8)

Percentage of less severe ulcers healed at 12 weeks

0 10 20 30 40 50 60 70 80 90 100

Service providers(n=69; median=33.3)

Percentage of severe ulcers healed at 12 weeks

32

Being ulcer free at 12 weeks and regression modelling To help explain the variation in observed 12 week healing between providers, associations between patient characteristics and 12 week healing outcomes were investigated using a statistical model. Full details can be found in Appendix 8.

Age, ethnicity, BMI, social deprivation, duration of diabetes and diabetes type were found not to be significant in predicting the 12 week healing. Based on these results, we would not expect a service to have a poorer outcome simply due to serving an older or more deprived population.

Individual SINBAD measures, presence of Charcot foot disease, time to assessment, sex and smoking status were all significant factors, with SINBAD and Charcot having the greatest impact. This suggests that the presence of Charcot disease or any of the SINBAD elements is expected to lead to worse outcomes.

Due to the low number of applicable cases (4,200), low case ascertainment (around 10 per cent) and variations in the quality and quantity of data submitted, caution should be applied when reviewing these findings. As data quality and coverage improve in future audits, we expect the model quality to also improve. We anticipate that this will allow us to assess service-level (NHS trust and LHB) 12 week healing rates in future reports.

33

Discussion and future plans

This is the first report from the National Diabetes Foot Care Audit (NDFA). It will now be continuous and provide annual measurement to support improvement in the outcomes of diabetic foot disease. There are two overriding objectives. The first is to determine the nature of geographical or service based variation in the outcome of diabetic foot ulcers throughout England and Wales. The second is to explore whether explanations for variation can be found from differences in the structures and processes of care in different centres.

Although some information on clinical outcomes from this initial audit is not yet available, the preliminary findings are of considerable interest. They confirm an association between ulcer severity at presentation to the expert team and the time taken to reach that team and they demonstrate an association between both ulcer severity and longer time to expert assessment and a reduced chance that the person will be ulcer-free at 12 weeks. To that end they endorse current NICE guidance regarding prompt referral of all newly occurring ulcers for expert assessment.

It is estimated that some 45,000 people would have presented with new ulcers in England and Wales during these first nine months of the audit and the details of just over 10 per cent of this total were included. This can be regarded as a very satisfactory result because it was inevitable that uptake by clinical centres would be gradual due to participation requiring some change in clinic routine (to accommodate individual patient consent). In addition, each centre had to secure its own local Caldicott Guardian approval for participation and this also introduced considerable delay. But by the end of the nine month inclusion period, cases were being registered by a total of 129 clinical teams representing 97 (77 per cent) of the 126 care providers (NHS Trusts and LHBs) registered with the audit.

It was possible to match 90 per cent of the selected cases with data held on the master NDA register and it is apparent that they were largely representative of the total population of people with diabetes in terms of demographics and characteristics of their disease. The registered ulcers also demonstrated the expected spread of severity from the least to most severe and the median time to healing was that predicted, with only 50 per cent of the surviving population being ulcer-free at three months. There was a clear relationship between presenting ulcer severity and likelihood of healing at three months.

40 per cent of localities were unable to respond to the short questionnaire on the structure of care available for diabetic foot disease in their area and only 60 per cent of those that responded were able to provide answers to all three questions. It follows that the attempt to assess links between the care structure and clinical outcome (healing by 12 weeks) had to be limited to the responses that had been received. No difference in outcome was observed between those providers who stated that there either was or was not a structured pathway for referral of foot ulcers. It is concerning that there appears to be a lack of awareness about the basic provision of foot care services for a condition with such a major impact on patients and the NHS.

Data on the time elapsing between first presentation to a health care professional and first expert assessment revealed quite marked variation, and was greater than 14 days in a quarter of cases. The time elapsed before first expert assessment was also associated both with greater ulcer severity and with reduced healing at 12 weeks and these observations lend force to current guidance that all new ulcers should be promptly assessed by an expert service. This first year of NDFA suggests, however, that in addition to these generic factors there is a quite marked variation in the rate of healing at 12 weeks between care providers in England (grouped by strategic clinical networks, SCNs) and Wales. When larger numbers are available next year, these data will require confirmation and may need to be adjusted for

34

case-mix as well as the variation in numbers of cases submitted by individual centres in each SCN.

Next year, details on all clinical outcomes (including whether the person is ulcer-free at 6 months, hospital admissions, ulcer recurrence and the incidence on minor and major amputations) will also be available and so it will be possible to explore linkage between all outcomes and both the structures and processes of care as well as to undertake more meaningful comparison between care providers. Ultimately, the quality promise of the NDFA is to help local health services eliminate variation, reduce healing times and thereby improve overall outcome by encouraging the adoption of good practice which is itself defined by the evidence generated from observations of routine clinical care in participating centres.

35

Further information

For more information on the National Diabetes Foot Care Audit or access to the Service Level Analysis, please visit the NDFA webpage at http://www.hscic.gov.uk/ndfa. For further information about this report, please contact the Health and Social Care Information Centre’s Contact Centre on 0300 303 5678 or email enquiries@hscic.gov.uk.

36

References

Abbott CA, Carrington AL, Ashe H, et al. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based cohort. Diabetes Med 2002; 19: 377–84.

Brownrigg JR et al. The association of ulceration of the foot with cardiovascular and all-cause mortality in patients with diabetes: a meta-analysis. Diabetologia 2012; 55: 2906-12.

Hosmer DW, Lemeshow S. Applied Logistic Regression (2nd Edition) New York, NY: John Wiley & Sons, 2000.

HSCIC (2016) National Diabetes Audit - 2013-2014 and 2014-2015: Report 1, Care Processes and Treatment Targets http://www.hscic.gov.uk/catalogue/PUB19900/nati-diab-rep1-audi-2013-15.pdf

Ince P, Abbas ZG, Lutale JK, et al. Use of the SINBAD classification system and score in comparing outcome of foot ulcer management on three continents. Diabetes Care 2008; 31:

964-7.

Kerr M (2012) Foot Care for People with Diabetes: the Economic Case for Change. NHS Diabetes and Kidney Care. http://www.diabetes.org.uk/Documents/nhs-diabetes/footcare/footcare-for-people-with-diabetes.pdf

NICE recommended care processes http://pathways.nice.org.uk/pathways/foot-care-for-people-with-diabetes.

NICE Guidelines: Diabetic foot problems: prevention and management; August 2015; http://www.nice.org.uk/guidance/ng19

ONS: Using Indices of Deprivation in the United Kingdom: Guidance Paper; April 2013; http://www.neighbourhood.statistics.gov.uk/HTMLDocs/images/UK%20wide%20guidance%20paper%20April%202013%20revision_tcm97-129456.pdf

37

Appendix 1: Methodology

The following section gives more detailed information on the methodology used in the NDFA report, looking at data collection, data linkage, report terminology and data analysis.

Data collection

NDFA Structures Survey

Commissioners of care for diabetic foot disease (CCGs in England and LHBs in Wales) were asked to complete a questionnaire on the structure of foot care services. Answers were collected in an online survey tool22. The survey was open from 22 October 2015 until 4 December 2015.

The three survey questions are provided in Appendix 2. Each question had the following options: ‘Yes’, ‘No’ or ‘Don’t know’. Commissioners could answer some, none or all of the questions in the survey.

There could be multiple responses from the same commissioner. If these answers directly conflicted with each other (‘Yes’ and ‘No’) then the organisation was listed as a ‘conflicted response’. If a definitive answer was submitted in tandem with an uncertain response or responses (e.g. ‘Yes’ and ‘Don’t know’), then the definitive response (‘Yes’ or ‘No’) was taken.

Responses under closed organisations were mapped to their successor organisations and answers from commissioning hubs were mapped to the CCGs they represent.

NDFA presentation and outcomes

Data on diabetic foot care presentation and outcomes was collected by specialist diabetes foot care teams and entered into the HSCIC Clinical Audit Platform (CAP). Data was collected on the ulcer characteristics of the worst ulcer on the patient’s first assessment for a new episode of diabetic foot ulceration. An encounter with the foot care service was considered to be a ‘first assessment’ if it was either the patient’s first encounter with the foot care service or if it was a repeat encounter, but the first following a period in which the patient was completely free of foot ulcers. A patient could be recorded multiple times in the audit, under the same or different foot care services, for each first attendance after intervals of being foot ulcer free.

The following data items were collected23: date of assessment, interval from the first presentation to a healthcare professional and assessment by the foot care service, the location of the ulcer, Charcot status and the SINBAD components (see Appendix 7) at first assessment. Follow up information regarding the patients’ foot ulcer status at 12 and 24 weeks was also collected.

The information in this report relates to patients who attended the first assessment of their foot ulcer at a participating service between 14 July 2014 and 10 April 2015. The data was extracted on 7 August 2015.

22

Survey Monkey: https://www.surveymonkey.com/ 23

NDFA Data Collection Form: http://www.hscic.gov.uk/media/14737/NDFA-Data-Collection-Form/pdf/NDFA_Data_Collection_Form_V2.1_FINAL.pdf

38

The NDFA is a consented audit. Patients were provided with information about the audit24 and completed a form giving consent to the use of their data25. Only data relating to consented patients was collected through the electronic system.

Linkage to other sources By linking to other datasets, the NDFA is able to analyse supplementary data without placing an additional collection burden on service providers.

National Diabetes Audit

NDFA data was linked to the core National Diabetes Audit (NDA). A full list of the NDA data items is provided in Appendix 6. Each NDA cohort is fifteen months long, beginning in January (for example January 2014 to March 2015). NDFA patients were linked to the latest three NDA core cohorts (2012-13, 2013-14 and 2014-15) using NHS number. Earlier NDA data was not included, as the information would be less relevant.

NDA coverage is not complete26, so not all NDFA patients could be linked. 4,522 (90.2 per cent) of NDFA patients were linked to the NDA, leaving 493 (9.8 per cent) NDFA patients with no NDA record. Of those that were matched to NDA, 3,391 (75.0 per cent) were linked to NDA 2014-15 data, 235 (5.2 per cent) to NDA 2013-14 data and 896 (19.8 per cent) to NDA 2012-13 data.

When comparing NDFA and NDA data, it should be noted that the information in the linked NDA data may not necessarily reflect the patient’s condition at the point of first attendance for foot ulceration. For example, the NDA collects the latest date care process and treatment target assessment within the NDA audit period27. To ensure foot reviews and treatment targets took place prior to the NDFA attendances, NDFA patients were linked to an earlier NDA audit year to confirm whether these took place between January 2013 and March 201428.

Hospital Episode Statistics and Patient Episode Database for Wales

Diabetic foot ulceration may require admission to hospital. The timing of Hospital Episode Statistics (HES) and Patient Episode Database for Wales (PEDW) data availability for the audit period means that analysis of hospital admissions and lower limb amputations could not be included in the first NDFA report, but is planned for subsequent reports.

24

NDFA Patient Information Leaflet: http://www.hscic.gov.uk/media/14739/NDFA-Patient-Information-Leaflet/pdf/NDFA_Patient_Information_Leaflet_v1.pdf 25

NDFA Consent Form: http://www.hscic.gov.uk/media/14736/NDFA-Consent-Form/pdf/NDFA_consent_form_v1.0.pdf 26

For example, participation for 2014-15 was around 57.3 per cent. HSCIC (2016) National Diabetes Audit - 2013-2014 and 2014-2015: Report 1, Care Processes and Treatment Targets http://www.hscic.gov.uk/catalogue/PUB19900/nati-diab-rep1-audi-2013-15.pdf 27

For the latest available NDA data, Jan-2014 to Mar-2015, an NDFA patient might be linked to a record where their NDA processes took place after their foot ulcer first assessment (NDFA) with no information about whether one took place earlier in that year. 28

The audit is therefore not directly comparing practice to the NICE guideline as the NDA recorded foot review may have taken place between five and 27 months prior to the patients’ first foot ulcer attendance with the foot care team.

39

Terminology

Patients and ulcers

There were 5,015 patients recorded in the audit. A single patient may appear multiple times with different ulcers. For example, they may present at a foot care service with a diabetic foot ulcer and then later begin a new episode of treatment for a diabetic foot ulcer after a period in which they were ulcer free. In total there were 5,215 ulcers recorded in the audit.

The report refers to ‘patients’ when counting each patient distinctly. This is primarily limited to descriptions of the characteristics of patients in the NDFA. The term ‘people with diabetes’ is used to describe the wider NDA cohort, who may not be ‘patients’ at a given time. The report refers to ‘ulcers’ or ‘cases’ interchangeably when counting distinct NDFA attendances. If a patient has two ulcers in the audit they would be counted twice. This method of counting is used through the majority of the report.

Organisations

The NDFA Structures Survey focuses on the commissioners of foot care services: CCGs in England and LHBs in Wales.

The NFDA processes and outcomes audit focuses on the service providers: NHS trusts, LHB or independent health care providers (IHPs).

Commissioners decide what health services are needed and ensure that they are provided. 209 CCGs in England and seven LHBs in Wales are responsible for commissioning healthcare services.

Foot care services are individual specialist services that treat people with diabetic foot ulcers. This includes community and hospital based organisations, as well as any GP practice that provides a specialist diabetic foot treatment service.

Service providers are the foot care service’s parent organisation. This is typically an NHS trust in England or a LHB in Wales. It may also be an IHP.

A single service provider may be responsible for multiple foot care services. For example, a single service provider responsible for three foot care services might run an integrated diabetes service at one hospital, see outpatients at a health centre and provide community podiatry in the locality. Providers registered as many foot care services with the audit as necessary to represent local service provision and organisation.

40

Analysis

Denominators

Most analysis in this report consists of descriptive statistics shown as tables or charts. Information is reported as counts and percentages and reported at national (England and Wales combined) level. Breakdowns in the local level reports are at service provider, CCG and SCN level.

For most of the analyses the denominator is either all cases collected in the NDFA (5,215) or patients linked to NDA (4,522). Some analyses require the recording of specific fields, so the base number of patients or ulcers is a sub-group of the NDFA or NDA-linked cohorts.

Deprivation and geography

Local measures of deprivation are not typically produced UK-wide, but on a country-by-country basis. Each country considers different factors and uses different calculation methods. In order to compare deprivation in England and Wales, deprivation quintiles have been assigned based on an equally weighted combination of the individual scores for the employment and income indices based on methodology designed by the Office for National Statistics (ONS)29.

The deprivation measures are based on Lower Super Output Area (LSOA), a geographical breakdown of England and Wales into approximately 35,000 regions, each containing about 1,500 people30. Where necessary, the LSOA taken from the linked NDA data has been updated to reflect the redrawing of area boundaries in 2011.

To find the deprivation quintile associated with patients in the NDFA, their LSOA was taken as that which was recorded at the time of the NDA data collection, with the caveat that patients may have moved between the time of the NDA data collection and the time of their foot assessment attendance in the NDFA.

Observed and case-mix adjusted results

When provider level comparisons are made, ‘observed’ results are those which are derived directly from the underlying data, with no attempt to adjust for differences between provider populations.

By contrast, ‘case-mix adjustment’ uses a statistical model to adjust the results of a measure to account for differences in the underlying data. An example of this is, if adjustment were applied to account for the fact that some foot care services treat more severe foot ulcerations than others, and so they would be more likely to have poorer outcomes recorded against them. Case-mix adjustment has not been applied to this year’s cohort (see Appendix 8).

29 ONS (2013) Using Indices of Deprivation in the United Kingdom p.7

http://www.neighbourhood.statistics.gov.uk/HTMLDocs/images/UK%20wide%20guidance%20paper%20April%202013%20revision_tcm97-129456.pdf 30

ONS: Super Output Area (SOA) http://www.ons.gov.uk/ons/guide-method/geography/beginner-s-guide/census/super-output-areas--soas-/index.html

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Appendix 2: NDFA Structures Survey

Please answer the following 3 questions about the structure of care for diabetic foot disease for your CCG or LHB area: 1. Training for Routine Diabetic Foot Examinations

o Is there a training programme designed to ensure that all responsible health care professionals have the necessary competence to undertake foot risk examinations as part of routine annual diabetes review?

2. Foot Protection Service* Pathway

o Is there an established pathway for referral of all people with diabetes who are defined as being at increased risk during annual foot examination to a designated Foot Protection Service? Such referral should enable further expert assessment and long term risk management and these require contractual standards, relating to:

waiting times; re-call and review processes; referral thresholds and pathways into and back from the Multidisciplinary

Foot Care Team or Service (MDFT or MDFS)

*Foot Protection Service means a service which is usually podiatry-led and community based, that

provides a recall and review system, patient education, callus/nail/skin management and offloading and the provision of advice and/or provision of appropriate care for people with diabetes who have feet at increased risk of ulceration.

3. New Foot Disease Pathway o For a person with new, deteriorating or recurrent diabetic foot disease is there an

established pathway which can allow referral to an expert assessment within 24 hours, if needed?

Additional information to be captured:

o Name of CCG area o Contact name, role and email address

42

Appendix 3: Participating foot care services

Services that submitted cases for the first audit report.

England

Trust Service name

Cheshire and Merseyside

Countess of Chester Hospital NHS Foundation Trust

Countess of Chester Hospital

Royal Liverpool and Broadgreen University Hospitals NHS Trust

The Royal Liverpool and Broadgreen University Hospitals NHS Trust

St Helens and Knowsley Hospitals NHS Trust Diabetes Centre, St Helens Hospital

East Midlands

Derby Teaching Hospitals NHS Foundation Trust Royal Derby Hospital Diabetic Foot Clinic

Derbyshire Community Health Services NHS Foundation Trust

Buxton Hospital High Peaks and Dales Podiatry

Kettering General Hospital NHS Foundation Trust

Northamptonshire Healthcare FT - Kettering Team

Northampton General Hospital NHS Trust Northamptonshire Healthcare Foundation Trust - Podiatry

Nottingham University Hospitals NHS Trust Nottingham University Hospitals Diabetes Foot Clinic Service

Sherwood Forest Hospitals NHS Foundation Trust

Kings Mill Hospital Podiatry

United Lincolnshire Hospitals NHS Trust Lincoln County Hospital - Podiatry

University Hospitals of Leicester NHS Trust UHL Multidisciplinary Diabetic Foot Clinic

East of England

Bedford Hospital NHS Trust Bedford Hospital Diabetes Foot Service

Cambridge University Hospitals NHS Foundation Trust

Addenbrooke's Hospital

East and North Hertfordshire NHS Trust MDT Foot Clinic at Hertford County Hospital

MDT Foot Clinic at Queen Elizabeth II Hospital

MDT Foot Clinic at The Lister Hospital

East Coast Community Healthcare C.I.C. East Coast Community Healthcare CIC

Hertfordshire Community NHS Trust Hertfordshire Podiatry Service

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norfolk and Norwich University Hospital

Provide Provide - Podiatry

South Essex Partnership University NHS Foundation Trust

SEPT Community Podiatry (Luton and South Beds), including Luton and Dunstable Hospital

South East and South West Essex Community Services

West Essex Community Podiatry Service

The Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust

The Queen Elizabeth Hospital

West Hertfordshire Hospitals NHS Trust West Hertfordshire Hospitals NHS Trust Acute Diabetes Foot Service

West Suffolk NHS Foundation Trust West Suffolk Hospital

43

Greater Manchester, Lancashire and South Cumbria

Bolton NHS Foundation Trust Diabetes Centre, Bolton NHS Foundation Trust

Central Manchester University Hospitals NHS Foundation Trust

Manchester Royal Infirmary

Lancashire Care NHS Foundation Trust Greater Preston Community Podiatry Service

Lancashire Teaching Hospitals NHS Foundation Trust

Chorley and South Ribble District Hospital

Pennine Acute Hospitals NHS Trust Fairfield General Hospital

North Manchester General Hospital

Pennine Care NHS Foundation Trust Bury Community Services - Podiatry

Heywood Middleton and Rochdale Community Services - Podiatry

Oldham Community Services - Podiatry

Trafford Community Services - Podiatry

Salford Royal NHS Foundation Trust Salford Royal NHS Foundation Trust

Southport and Ormskirk Hospital NHS Trust North Sefton High Risk Podiatry

Southport and Formby District General Hospital

West Lancs High Risk Podiatry

Stockport NHS Foundation Trust Stockport FT Podiatry

London

Croydon Health Services NHS Trust Croydon Health Services NHS Trust - Podiatry

Healthshare Ltd Healthshare Community Podiatry Services

Imperial College Healthcare NHS Trust Imperial College Healthcare NHS Trust

King's College Hospital NHS Foundation Trust Kings College Hospital, Diabetic Foot Clinic, Denmark Hill

Lewisham and Greenwich NHS Trust University Hospital Lewisham

London North West Healthcare NHS Trust Brent Integrated Diabetes Foot Service

Ealing Hospital

Northwick Park Hospital Podiatry Clinic

North Middlesex University Hospital NHS Trust North Middlesex University Hospital

Royal Free London NHS Foundation Trust Acute Foot Multidisciplinary Team, Royal Free Hospital

The Whittington Hospital NHS Trust Whittington Hospital - Podiatry

University College London Hospitals NHS Foundation Trust

UCLH Podiatry

Northern England

City Hospitals Sunderland NHS Foundation Trust City Hospitals Sunderland Diabetes Foot Clinic

County Durham and Darlington NHS Foundation Trust

County Durham and Darlington Foundation Trust - Podiatry

Gateshead Health NHS Foundation Trust QE Diabetic Services at Trinity Square

North Tees and Hartlepool NHS Foundation Trust

North Tees and Hartlepool NHS Trust

Northumbria Healthcare NHS Foundation Trust

Northumbria Community Podiatry

Northumbria Diabetes Specialist Podiatry

South Tees Hospitals NHS Foundation Trust The James Cook University Hospital Diabetes Care Centre

South Tyneside NHS Foundation Trust Gateshead Community Podiatry Team

South Tyneside Community Podiatry Team

South Tyneside Inpatient Podiatry Team

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle Upon Tyne Hospitals Podiatry Department

44

South East Coast

Ashford and St Peter's Hospitals NHS Foundation Trust

Ashford and St Peter’s NHS Foundation Trust

CSH Surrey CSH Surrey

Dartford and Gravesham NHS Trust Darent Valley Hospital Diabetes Foot MDT

East Kent Hospitals University NHS Foundation Trust

QEQM Hospital, Kent and Canterbury Hospital and William Harvey Hospital

East Sussex Healthcare NHS Trust East Sussex Healthcare NHS Trust - Podiatry

First Community Health and Care CIC First Community Health and Care Podiatry Service

Frimley Health NHS Foundation Trust Frimley Park Hospital

Maidstone and Tunbridge Wells NHS Trust Maidstone Hospital, Tunbridge Wells Hospital

Medway NHS Foundation Trust Inpatient and Outpatient Specialist Podiatry Service

Royal Surrey County Hospital NHS Foundation Trust

Royal Surrey County Hospital

Western Sussex Hospitals NHS Foundation Trust Western Sussex Hospitals - Podiatry

South West

Dorset County Hospital NHS Foundation Trust Dorset Healthcare University NHS Foundation Trust - Nail Surgery and Biomechanics

Gloucestershire Care Services NHS Trust Gloucestershire Podiatry Service

Great Western Hospitals NHS Foundation Trust Great Western Hospital

Great Western Hospitals Foundation NHS Trust - Community Podiatry

Northern Devon Healthcare NHS Trust Northern Devon Healthcare NHS Trust

Royal Devon and Exeter NHS Foundation Trust Royal Devon and Exeter Hospital

Salisbury NHS Foundation Trust Salisbury District Hospital

Torbay and Southern Devon Health and Care NHS Trust

Torbay and Southern Devon Health and Care NHS Trust

University Hospitals Bristol NHS Foundation Trust

Bristol Royal Infirmary - Podiatry

Wye Valley NHS Trust Diabetic Foot Clinic

Thames Valley

Buckinghamshire Healthcare NHS Trust Stoke Mandeville - Podiatry

Wycombe Hospital - Podiatry

Royal Berkshire NHS Foundation Trust Royal Berkshire Hospital MDFT

Wessex

Poole Hospital NHS Foundation Trust Poole Hospital

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth Diabetes and Endocrine Centre

West Midlands

Birmingham Community Healthcare NHS Trust Birmingham Community Healthcare NHS Trust Podiatry Service

Heart of England NHS Foundation Trust Heartlands Hospital Diabetic Foot Clinic

Solihull Hospital

Sandwell and West Birmingham Hospitals NHS Trust

Sandwell and City Hospitals

South Warwickshire NHS Foundation Trust Warwick Hospital

Staffordshire and Stoke on Trent Partnership NHS Trust

Staffordshire and Stoke on Trent Partnership Trust

University Hospitals Coventry and Warwickshire NHS Trust

Wisdem Diabetes Outpatient Foot Clinic

Worcestershire Health and Care NHS Trust Worcestershire NHS Podiatry Service

45

Yorkshire and the Humber

Bradford District Care NHS Foundation Trust Bradford Foot Care, Diabetes Unit

Calderdale and Huddersfield NHS Foundation Trust

Calderdale Royal Hospital and Huddersfield Royal Infirmary

Harrogate and District NHS Foundation Trust Harrogate Hospital

Humber NHS Foundation Trust Hull and East Yorkshire Hospitals

Leeds Teaching Hospitals NHS Trust Leeds - Podiatry

Mid Yorkshire Hospitals NHS Trust Pinderfields Hospital

Pontefract Hospital

Northern Lincolnshire and Goole NHS Foundation Trust

Diana Princess of Wales Hospital

Scunthorpe General Hospital

Sheffield Teaching Hospitals NHS Foundation Trust

Northern General Hospital, Sheffield

Royal Hallamshire Hospital - Podiatry

The Rotherham NHS Foundation Trust Rotherham General Hospital

York Teaching Hospital NHS Foundation Trust Podiatry Services - Scarborough Locality

Podiatry Services - York and Selby Locality

Wales

Local Health Board Service name

Abertawe Bro Morgannwg University LHB Morriston Hospital Diabetes Centre Podiatry Department

Neath Port Talbot Hospital Podiatry Department

Princess of Wales Hospital Diabetes Centre

Aneurin Bevan University LHB Podiatry and Orthotics Services

Betsi Cadwaladr University LHB Wrexham Maelor Hospital

Ysbyty Glan Clwyd

Ysbyty Gwynedd

Cardiff and Vale University LHB Cardiff Royal Infirmary - Podiatry

St Davids Community Hospital - Podiatry

The Barry Hospital

University Hospital Llandough - Podiatry

University Hospital of Wales - Podiatry

Cwm Taf University LHB Prince Charles Hospital and Royal Glamorgan Hospital

Hywel Dda University LHB Bronglais General Hospital

Prince Philip Hospital

Withybush General Hospital

Powys Teaching LHB Powys Teaching Health Board - Podiatry

Additional services participating in the audit by 18 January 2016.

England

Trust Service name

Cheshire and Merseyside

Aintree University Hospital NHS Foundation Trust

Aintree Hospital NHS Foundation Trust - Podiatry

East Cheshire NHS Trust Macclesfield District General Hospital - Podiatry

Warrington and Halton Hospitals NHS Foundation Trust

Diabetic Foot Clinic

46

Trust Service name

East of England

Cambridgeshire Community Services NHS Trust Podiatry Department Oak Tree Health Centre

Ipswich Hospital NHS Trust The Ipswich Hospital Diabetic Foot Clinic

Greater Manchester, Lancashire and South Cumbria

Stockport NHS Foundation Trust Tameside and Glossop Integrated Diabetes Service

London

Lewisham and Greenwich NHS Trust Oxleas NHS Foundation Trust - Podiatry

North East London NHS Foundation Trust Chadwell Heath Health Centre

Harold Hill Health Centre

Harold Wood – Long Term Conditions Centre

Porters Avenue

Queens Hospital

South Hornchurch Health Centre

South West

North Somerset Community Partnership Community Interest Company

North Somerset Community Partnership Podiatry Service

Sirona Care and Health Podiatry - Patchway Clinic

Podiatry - St Martins Outpatient Clinic

Thames Valley

Heatherwood and Wexham Park Hospitals NHS Foundation Trust

Wexham Park Hospital Multidisciplinary Foot Care Team

Oxford University Hospitals NHS Trust Diabetic Foot Clinic, OCDEM

West Midlands

The Dudley Group NHS Foundation Trust Dudley Diabetes Foot Care Services

Yorkshire and the Humber

Mid Yorkshire Hospitals NHS Trust Dewsbury Hospital

Wales

Local Health Board Service name

Hywel Dda University Local Health Board Glangwili General Hospital

47

Appendix 4: Locations of participating foot care services

Figure 13 shows the geographic distribution of participating service providers across England and Wales, with each foot care service site highlighted in white.

Figure 13: Map of participating service providers, by foot care service, England and Wales, 2014-2015^

^ Multiple services within the same organisation may operate from the same site or from sites that are geographically close and these may not be distinguishable on the map. Service providers continue to join the audit, and sites that have only provided more recent data do not appear in this map.

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Appendix 5: Participating commissioning organisations

Commissioning organisations (CCGs and LHBs) that participated in the NDFA Structures Survey31.

Organisation Name Participated in structures audit

Patients from this CCG / LHB were submitted to the audit

Unknown CCG / LHB Yes32

NHS England London

NHS Barking and Dagenham CCG Yes

NHS Barnet CCG Yes Yes

NHS Bexley CCG Yes

NHS Brent CCG Yes Yes

NHS Bromley CCG Yes

NHS Camden CCG Yes

NHS Central London (Westminster) CCG Yes Yes

NHS City and Hackney CCG Yes Yes

NHS Croydon CCG Yes Yes

NHS Ealing CCG Yes Yes

NHS Enfield CCG Yes Yes

NHS Greenwich CCG Yes

NHS Hammersmith and Fulham CCG Yes Yes

NHS Haringey CCG Yes

NHS Harrow CCG Yes

NHS Havering CCG

NHS Hillingdon CCG Yes

NHS Hounslow CCG Yes Yes

NHS Islington CCG Yes Yes

NHS Kingston CCG Yes

NHS Lambeth CCG Yes Yes

NHS Lewisham CCG Yes Yes

NHS Merton CCG

NHS Newham CCG Yes Yes

NHS Redbridge CCG Yes Yes

NHS Richmond CCG Yes Yes

NHS Southwark CCG Yes

NHS Sutton CCG Yes Yes

NHS Tower Hamlets CCG Yes Yes

NHS Waltham Forest CCG Yes Yes

NHS Wandsworth CCG Yes Yes

NHS West London CCG Yes Yes

31

Four specialist commissioning hubs also responded to the NDFA structures audit – West Midlands, Cheshire and Merseyside, Lancashire and Greater Manchester, and South Central Commissioning Hub. 32

493 (9.8 per cent) of the 5,015 patients submitted to the NDFA could not be linked to the NDA, and so could not be allocated to a CCG / LHB as the responsible commissioning organisation for their care.

49

NHS England Midlands and East (Central Midlands)

NHS Bedfordshire CCG Yes Yes

NHS Corby CCG Yes

NHS East and North Hertfordshire CCG Yes Yes

NHS East Leicestershire and Rutland CCG Yes

NHS Herts Valleys CCG Yes Yes

NHS Leicester City CCG Yes Yes

NHS Lincolnshire East CCG Yes

NHS Lincolnshire West CCG Yes

NHS Luton CCG Yes

NHS Milton Keynes CCG Yes

NHS Nene CCG Yes

NHS South Lincolnshire CCG Yes

NHS South West Lincolnshire CCG Yes Yes

NHS West Leicestershire CCG Yes

NHS England Midlands and East (East)

NHS Basildon and Brentwood CCG Yes Yes

NHS Cambridgeshire and Peterborough CCG Yes Yes

NHS Castle Point and Rochford CCG Yes Yes

NHS Great Yarmouth and Waveney CCG Yes Yes

NHS Ipswich and East Suffolk CCG Yes

NHS Mid Essex CCG Yes Yes

NHS North East Essex CCG

NHS North Norfolk CCG Yes

NHS Norwich CCG Yes Yes

NHS South Norfolk CCG Yes

NHS Southend CCG Yes Yes

NHS Thurrock CCG Yes

NHS West Essex CCG Yes Yes

NHS West Norfolk CCG Yes Yes

NHS West Suffolk CCG Yes

NHS England Midlands and East (North Midlands)

NHS Cannock Chase CCG Yes

NHS East Staffordshire CCG Yes Yes

NHS Erewash CCG Yes

NHS Hardwick CCG Yes Yes

NHS Mansfield and Ashfield CCG Yes Yes

NHS Newark & Sherwood CCG Yes

NHS North Derbyshire CCG Yes Yes

NHS North Staffordshire CCG Yes Yes

NHS Nottingham City CCG Yes Yes

NHS Nottingham North and East CCG Yes Yes

NHS Nottingham West CCG Yes Yes

NHS Rushcliffe CCG Yes

NHS Shropshire CCG Yes Yes

NHS South East Staffordshire and Seisdon Peninsula CCG

Yes

NHS Southern Derbyshire CCG Yes Yes

NHS Stafford and Surrounds CCG Yes

50

NHS Stoke on Trent CCG Yes Yes

NHS Telford and Wrekin CCG Yes

NHS England Midlands and East (West Midlands)

NHS Birmingham Crosscity CCG Yes

NHS Birmingham South and Central CCG Yes Yes

NHS Coventry and Rugby CCG Yes

NHS Dudley CCG Yes Yes

NHS Herefordshire CCG Yes Yes

NHS Redditch and Bromsgrove CCG

NHS Sandwell and West Birmingham CCG Yes

NHS Solihull CCG Yes Yes

NHS South Warwickshire CCG Yes

NHS South Worcestershire CCG Yes Yes

NHS Walsall CCG Yes Yes

NHS Warwickshire North CCG Yes

NHS Wolverhampton CCG Yes

NHS Wyre Forest CCG Yes

NHS England North (Cheshire and Merseyside)

NHS Eastern Cheshire CCG Yes

NHS Halton CCG Yes Yes

NHS Knowsley CCG Yes Yes

NHS Liverpool CCG Yes Yes

NHS South Cheshire CCG

NHS South Sefton CCG Yes

NHS Southport and Formby CCG Yes Yes

NHS St Helens CCG Yes

NHS Vale Royal CCG Yes

NHS Warrington CCG Yes

NHS West Cheshire CCG Yes Yes

NHS Wirral CCG

NHS England North (Cumbria and North East)

NHS Cumbria CCG Yes Yes

NHS Darlington CCG Yes Yes

NHS Durham Dales, Easington and Sedgefield CCG Yes Yes

NHS Hartlepool and Stockton-On-Tees CCG Yes

NHS Newcastle Gateshead CCG Yes Yes

NHS North Durham CCG Yes Yes

NHS North Tyneside CCG Yes

NHS Northumberland CCG Yes

NHS South Tees CCG Yes Yes

NHS South Tyneside CCG Yes Yes

NHS Sunderland CCG Yes Yes

51

NHS England North (Lancashire and Greater Manchester)

NHS Blackburn with Darwen CCG Yes

NHS Blackpool CCG Yes Yes

NHS Bolton CCG Yes Yes

NHS Bury CCG Yes Yes

NHS Central Manchester CCG Yes

NHS Chorley and South Ribble CCG Yes

NHS East Lancashire CCG Yes

NHS Fylde & Wyre CCG Yes Yes

NHS Greater Preston CCG Yes

NHS Heywood, Middleton and Rochdale CCG Yes Yes

NHS Lancashire North CCG

NHS North Manchester CCG Yes Yes

NHS Oldham CCG Yes

NHS Salford CCG Yes

NHS South Manchester CCG Yes Yes

NHS Stockport CCG Yes

NHS Tameside and Glossop CCG Yes

NHS Trafford CCG Yes Yes

NHS West Lancashire CCG Yes Yes

NHS Wigan Borough CCG Yes

NHS England North (Yorkshire and Humber)

NHS Airedale, Wharfedale and Craven CCG Yes Yes

NHS Barnsley CCG Yes

NHS Bassetlaw CCG Yes

NHS Bradford City CCG Yes

NHS Bradford Districts CCG Yes Yes

NHS Calderdale CCG Yes Yes

NHS Doncaster CCG Yes

NHS East Riding of Yorkshire CCG Yes Yes

NHS Greater Huddersfield CCG Yes Yes

NHS Hambleton, Richmondshire and Whitby CCG Yes

NHS Harrogate and Rural District CCG Yes Yes

NHS Hull CCG Yes Yes

NHS Leeds North CCG Yes

NHS Leeds South and East CCG Yes Yes

NHS Leeds West CCG Yes Yes

NHS North East Lincolnshire CCG Yes Yes

NHS North Kirklees CCG Yes Yes

NHS North Lincolnshire CCG Yes

NHS Rotherham CCG Yes

NHS Scarborough and Ryedale CCG Yes

NHS Sheffield CCG Yes Yes

NHS Vale of York CCG Yes Yes

NHS Wakefield CCG Yes Yes

52

NHS England South (South Central)

NHS Aylesbury Vale CCG Yes Yes

NHS Bath and North East Somerset CCG Yes

NHS Bracknell and Ascot CCG Yes

NHS Chiltern CCG Yes

NHS Gloucestershire CCG Yes Yes

NHS Newbury and District CCG Yes

NHS North & West Reading CCG Yes Yes

NHS Oxfordshire CCG Yes Yes

NHS Slough CCG Yes

NHS South Reading CCG Yes

NHS Swindon CCG Yes Yes

NHS Wiltshire CCG Yes

NHS Windsor, Ascot and Maidenhead CCG

NHS Wokingham CCG Yes

NHS England South (South East)

NHS Ashford CCG Yes

NHS Brighton and Hove CCG Yes

NHS Canterbury and Coastal CCG Yes Yes

NHS Coastal West Sussex CCG Yes Yes

NHS Crawley CCG Yes

NHS Dartford, Gravesham and Swanley CCG Yes Yes

NHS East Surrey CCG Yes

NHS Eastbourne, Hailsham and Seaford CCG Yes Yes

NHS Guildford and Waverley CCG Yes Yes

NHS Hastings and Rother CCG Yes

NHS High Weald Lewes Havens CCG Yes

NHS Horsham and Mid Sussex CCG

NHS Medway CCG Yes Yes

NHS North West Surrey CCG Yes

NHS South Kent Coast CCG Yes Yes

NHS Surrey Downs CCG Yes Yes

NHS Surrey Heath CCG Yes

NHS Swale CCG Yes Yes

NHS Thanet CCG Yes

NHS West Kent CCG Yes

NHS England South (South West)

NHS Bristol CCG Yes Yes

NHS Kernow CCG Yes

NHS North Somerset CCG Yes

NHS Northern, Eastern and Western Devon CCG Yes Yes

NHS Somerset CCG Yes Yes

NHS South Devon and Torbay CCG Yes Yes

NHS South Gloucestershire CCG Yes

53

NHS England South (Wessex)

NHS Dorset CCG Yes Yes

NHS Fareham and Gosport CCG

NHS Isle of Wight CCG

NHS North East Hampshire and Farnham CCG Yes

NHS North Hampshire CCG Yes Yes

NHS Portsmouth CCG

NHS South Eastern Hampshire CCG Yes

NHS Southampton CCG Yes

NHS West Hampshire CCG Yes Yes

NHS Wales

Abertawe Bro Morgannwg University LHB Yes Yes

Aneurin Bevan University LHB Yes Yes

Betsi Cadwaladr University LHB Yes

Cardiff and Vale University LHB Yes Yes

Cwm Taf University LHB Yes

Hywel Dda University LHB Yes Yes

Powys Teaching LHB Yes

54

Figure 14: Map of responsible commissioners and their participation in the structures survey, England and Wales, 2014-2015^

Figure 15: Map of responsible commissioners of patients submitted in the audit, England and Wales, 2014-2015†

^ Participating organisations may have answered any number (0-3) of the three survey questions. † 493 patients could not be linked to the NDA and assigned to a commissioner.

55

Appendix 6: NDA data items collected via linkage

The following NDFA data items were collected from the NDA Core via linkage:

Appendix 7: SINBAD scores

The audit recorded the severity of the patient’s index ulcer using the yes/no scoring system SINBAD. The scoring system assesses six aspects of the ulcer –

Site –Where index ulcer is found on the hindfoot (including the tarso-metatarsal joints and everything proximal to them below the ankle [Yes]. Or when it is sited elsewhere [No].

Ischaemia - Where pulses are absent and/or there are other clinical signs of ischaemia [Yes]. Or where pulses are intact and there’s no sign of ischaemia [No].

Neuropathy – Where there is evidence of sensory loss using monofilament or touch or vibration or other stimulus used in routine clinical practice [Yes]. Or where there is no evidence of sensory loss [No].

Bacterial infection – Where there are clinical signs of infection, such as redness, swelling, heat, discharge, etc. [Yes]. Or where there are no clinical signs of infection [No].

Area – Where the index ulcer has an area of 1cm2 or more [Yes]. Or where the area is less than 1cm2 [No].

Depth – Where the ulcer – assessed by eye or sterile probe – reaches tendon or bone [Yes]. Or where the ulcer does not penetrate that far [No].

For each ulcer, the more severe variant of each SINBAD aspect is scored with 1 and the less severe variant is scored with 0. An ulcer may have an overall SINBAD score between 0 (least severe) and 6 (most severe).

Data item

Age

Sex

LSOA

Ethnicity

Diabetes type

Year of diagnosis

BMI

Smoking history

Last foot exam

Last HbA1c

Last BP systolic

Last BP diastolic

Last cholesterol

56

Appendix 8: Regression modelling of 12 week outcomes Logistic regression has been used to investigate associations between the audit variables and 12 week healing outcomes.

Taken as a whole, the derived model did not predict with sufficient certainty whether an individual was likely to be ulcer free at 12 weeks (c-statistic33 of 0.69). Therefore the performance of individual providers in the data is not explained by the demographics of the patients they have submitted.

This model will be reconsidered in later audit years when there will be more data available to inform the model. The audit will then look towards providing standardised healing ratios by organisations to indicate the relative performance of providers of diabetic foot care.

Regression model variables

Variables considered as possible explanatory factors for 12 week healing were age, sex, ethnicity, deprivation quintile, BMI, smoking status, diabetes type, diabetes duration, Charcot foot disease, each SINBAD component and time to assessment. The following were found to have a significant association with 12 week healing outcomes: sex, smoking status, Charcot foot disease, the SINBAD components and time to assessment (see Table 14 below).

Table 14: 12 week healing regression modelling variables, England and Wales, 2014-2015

Variable Significant association with 12 week healing found?

Age No

Sex Yes

Ethnicity No

Deprivation quintile No

BMI Excluded*

Smoking status Yes

Diabetes type No

Diabetes duration Excluded*

Charcot foot disease

Yes

SINBAD components

Yes (all)

Time to assessment

Yes

* In early iterations of the model, BMI and then diabetes duration only showed a significant association to healing amongst patients for whom no value was recorded in the variable, and no differences between different recorded values. These variables were subsequently excluded from consideration for the final model.

33

See explanatory note at the foot of Table 15.

57

Regression model outputs

Table 15 below shows the results from the regression model.

Table 15: Results from multivariate analysis of data for ulcer free outcomes at 12 weeks, England

and Wales, 2014-2015^

Number of observations used in model 4,200

Filters Outcome: Survived at 12 weeks, Sex: Male, Female

Intercept Estimate 95% CI Limits

1.21 (0.98, 1.43)

c-statistic * 0.69

Odds Ratio 95% CI Limits

Sex Sex: Female vs. Male 1.199 (1.040, 1.384)

Time to assessment Self-presenting reference category

<=2 days vs. Self-presenting 0.881 (0.717, 1.083)

3-13 days vs. Self-presenting 0.909 (0.767, 1.076)

14 days - 2 months vs. Self-presenting 0.716 (0.592, 0.865)

> 2 months vs. Self-presenting 0.524 (0.399, 0.687)

Site Yes vs. No 0.763 (0.640, 0.910)

Ischaemia Yes vs. No 0.559 (0.487, 0.642)

Neuropathy Yes vs. No 0.741 (0.623, 0.881)

Bacterial Infection Yes vs. No 0.790 (0.685, 0.911)

Area Yes vs. No 0.497 (0.433, 0.570)

Depth Yes vs. No 0.613 (0.507, 0.742)

Charcot foot disease Not present reference category

Present vs. Not present 0.578 (0.431, 0.775)

Possible vs. Not present 1.204 (0.722, 2.008)

Not recorded vs. Not present 1.191 (1.002, 1.416)

Smoking status Current smoker vs Ex-smoker 0.751 (0.602, 0.938)

Ex-smoker reference category

Never smoked vs Ex-smoker 0.887 (0.752, 1.045)

Non-smoked, history unknown vs Ex-smoker 0.935 (0.669, 1.307)

Unknown/Not recorded vs Ex-smoker 0.724 (0.607, 0.864)

^ Text shown in black indicates where there is a significant difference compared to the reference group (<0.05). Text shown in grey indicates where there is not a significant difference compared to the reference group. Results are presented as odds ratios with 95% confidence intervals in brackets. * c statistic: The probability that predicting the outcome is better than chance. Used to compare the goodness of fit of logistic regression models, values for this measure range from 0.5 to 1.0. A value of 0.5 indicates that the model is no better than chance at making a prediction of membership in a group and a value of 1.0 indicates that the model perfectly identifies those within a group and those not. Models are typically considered reasonable when the c-statistic is higher than 0.7 and strong when the c-statistic exceeds 0.8 (Hosmer & Lemeshow, 2000)

34.

The odds ratios in Table 15 above illustrate how strongly each variable is associated with the outcome. An odds ratio of 1 would show that the variable has no bearing on how likely the outcome is. For example the odds ratio for ‘Bacterial Infection’ between ‘Yes’ and ‘No’ is 0.790; therefore someone with a bacterial infection is less likely to be ulcer free after 12 weeks than someone without such an infection.

34

Hosmer DW, Lemeshow S. Applied Logistic Regression (2nd Edition). New York, NY: John Wiley & Sons; 2000

58

The further from one the ratio is, the stronger the association between it and the outcome. The odds ratio for ischemia is 0.559, so whether this is present or not is a stronger predictor of being ulcer free than whether a bacterial infection is present.

There is always a degree of uncertainty in the calculated odds ratio. This is described by the confidence intervals. If the confidence intervals are either side of 1 this indicates that the variable has no bearing on how likely the outcome is.

The odds ratio results from the regression model show that the presence of each the SINBAD elements is associated with poorer healing outcomes, with the effect most pronounced where ulcers were greater than 1cm2 in area (Area) or where there were signs of impaired circulation (Ischaemia). Women tend to have better outcomes than men, as do ex-smokers compared to current smokers. Time to presentation is also shown to be significant, with intervals of 2 weeks or more associated with poorer outcomes than the reference category (self-presenters). This effect was most pronounced where the wait was two months or longer.

As noted above, the low c-statistic35 of 0.69 indicates that the model is insufficient for use to calculate standardised healing ratios, though this will hopefully be achievable in later years as participation, case ascertainment and data quality improve.

35

See explanatory note at the foot of Table 15.

59

Appendix 9: Characteristics of people in the NDFA

The following section compares the characteristics of people included in NDFA with the wider pool of diabetic patients in the NDA.

Diabetes type

Table 16 below shows that Type 1 diabetes is more prevalent (13.0 per cent) amongst those that present with a foot ulcer than in the diabetic population as a whole (8.6 per cent).

Table 16: Diabetes type of people with new ulcers compared to the total diabetic population, England and Wales, 2014-2015^

Diabetes type

NDFAi

(N=4,522) NDA 2014-15

ii

(N=1,894,887) Difference

Number Per cent Number Per cent %

Type 1 588 13.0 163,589 8.6 4.4

Type 2 and other 3,934 87.0 1,731,298 91.4 -4.4

^ Where the values in a row in the table are bolded, the difference between the two percentages is statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

Gender

Table 17 below shows that there is a higher proportion of men (69.6 per cent) in the NDFA cohort than in the total diabetic population (55.7 per cent), a difference of 13.9 percentage points.

Table 17: Gender of people with new ulcers compared to the total diabetic population, England and Wales, 2014-2015 †^

Gender

NDFAi

(N=4,521) NDA 2014-15

ii

(N=1,894,626) Difference

Number Per cent Number Per cent %

Male 3,148 69.6 1,055,533 55.7 13.9

Female 1,373 30.4 839,093 44.3 -13.9 † Not known/not recorded responses are not shown this table.

^ Where the values in a row in the table are emboldened, the difference between the two percentages is statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

Age

Table 18 below shows that the average age of people with diabetes who present with a foot ulcer (67.3 years) is higher than in the overall diabetic population (63.6 years). The difference is particularly pronounced in people with Type 1 diabetes.

Table 18: Average age recorded in NDA of people with new ulcers compared to the total diabetic population, by diabetes type, England and Wales, 2014-2015 †^

Diabetes type NDFA

i NDA 2014-15

ii Difference

Years Years Years

Type 1 55.7 42.9 12.8

Type 2 and other 69.1 65.5 3.6

All patients 67.3 63.6 3.8

^ Where the values in a row in the table are emboldened , the difference between the two numbers is statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

60

Duration of diabetes

Table 19 below shows that the average duration of diabetes for people who present with a foot ulcer is 6.4 years higher than in the diabetic population as a whole. The difference is more pronounced in people with Type 1 diabetes.

Table 19: Average duration of diabetes for people with new ulcers compared to the total diabetic population, by diabetes type, England and Wales, 2014-2015^

Diabetes type NDFA

i NDA 2014-15

ii Difference

Years Years Years

Type 1 26.5 17.6 8.9

Type 2 and other 13.3 7.8 5.5

All patients 15.0 8.6 6.4

^ Where the values in a row in the table are emboldened , the difference between the two numbers is statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

Ethnicity

Table 20 below shows that there is a higher proportion of people of a white ethnic background amongst those that present with a diabetic foot ulcer (69.9 per cent) compared to the diabetes population as a whole (61.4 per cent).

Table 20: Ethnicity of people with new ulcers compared to the total diabetic population, by diabetes type, England and Wales, 2014-2015^

Ethnic group

All diabetes

(N=4,522) Type 1

(N=588) Type 2 and other

(N=3,934)

NDFAi

NDAii

NDFAi

NDAii

NDFAi

NDAii

Number Per cent

Per cent

Number Per cent

Per cent

Number Per cent

Per cent

White 3,159 69.9 61.4 443 75.3 67.8 2,716 69.0 60.8

Mixed 17 0.4 0.9 2 0.3 0.9 15 0.4 0.9

Asian 116 2.6 9.4 5 0.9 3.3 111 2.8 9.9

Black 116 2.6 4.1 10 1.7 2.8 106 2.7 4.2

Other 71 1.6 2.6 8 1.4 2.1 63 1.6 2.6

Not stated/not known 1,043 23.1 21.7 120 20.4 23.1 923 23.5 21.6

^ Where the values in a row in the table are emboldened, the difference between the comparable NDFA and NDA percentages are statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

61

Deprivation

Table 21 below shows that there is a higher proportion of people in the most deprived fifth of the population amongst those that present with a diabetic foot ulcer (26.0 per cent) compared to the diabetic population as a whole (22.9 per cent). This suggests a positive correlation between deprivation severity and presentation with a diabetic foot ulcer. The effect is more pronounced for people with Type 1 diabetes (6.0 percentage points higher in NFDA patients) than for people with Type 2 diabetes (2.4 per cent percentage points higher).

Table 21: Deprivation quintile of people with new ulcers by diabetes type, England and Wales, 2014-2015†^

Deprivation quintile

All diabetes

(N=4,522) Type 1

(N=588) Type 2 and other

(N=3,934)

NDFAi

NDAii

NDFAi

NDAii

NDFAi

NDAii

Number Per cent

Per cent

Number Per cent

Per cent

Number Per cent

Per cent

Most deprived fifth 1,175 26.0 22.9 154 26.2 19.6 1,021 26.0 23.3

2nd

most deprived fifth 932 20.6 22.5 105 17.9 20.8 827 21.0 22.6

3rd

most deprived fifth 936 20.7 20.6 129 21.9 20.6 807 20.5 20.6

2nd

least deprived fifth 831 18.4 18.4 111 18.9 20.0 720 18.3 18.2

Least deprived fifth 637 14.1 15.6 88 15.0 19.0 549 14.0 15.3 † The percentages for each year do not add up to 100 per cent as “Not known/not recorded” responses have not been

included in this table.

^ Where the values in a row in the table are emboldened , the difference between the comparable NDFA and NDA percentages are statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

Body mass index (BMI)

Table 22 shows that the average BMI of people who present with a foot ulcer (31.1 kg/m2) is higher than in the diabetic population as a whole (30.8 kg/m2), although the difference is small (0.3 kg/m2). The difference is more pronounced for people with Type 1 diabetes.

Table 22: Average BMI of people with new ulcers compared to the total diabetic population, by diabetes type, England and Wales, 2014-2015^

Diabetes type NDFA

i NDA 2014-15

ii Difference

kg/m2 kg/m

2I kg/m

2

Type 1 28.1 26.9 1.3 Type 2 and other 31.6 31.1 0.5 All patients 31.1 30.8 0.3

^ Where the values in a row in the table are emboldened , the difference between the two numbers is statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

62

Smoking status

Table 23 below shows that the proportion of Type 1 patients that are current or ex-smokers is 10.4 percentage points higher than the equivalent NDA cohort. There is no significant difference for the equivalent group of people with Type 2 diabetes.

Table 23: Smoking status of people with new ulcers compared to the total diabetic population, by diabetes type, England and Wales, 2014-2015^

Smoking status

All diabetes

(N=4,522) Type 1

(N=588) Type 2 and other

(N=3,934)

NDFAi

NDAii

NDFAi

NDAii

NDFAi

NDAii

Number Per cent

Per cent

Number Per cent

Per cent

Number Per cent

Per cent

Current smoker 532 11.8 12.6 112 19.0 15.4 420 10.7 12.3

Ex-smoker 1,421 31.4 30.0 144 24.5 17.7 1,277 32.5 31.2

Non-smoker, history unknown

173 3.8 1.1 21 3.6 2.1 152 3.9 1.0

Never smoked 1,316 29.1 38.2 169 28.7 36.6 1,147 29.2 38.3

Not known 1,080 23.9 18.2 142 24.1 28.2 938 23.8 17.2

^ Where the values in a row in the table are emboldened , the difference between the comparable NDFA and NDA percentages are statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

NICE recommended treatment targets NICE has defined treatment targets for HbA1c (glucose control), blood pressure and serum cholesterol. The targets are important because:

• Target HbA1c (≤58 mmol/mol) reduces the risk of all diabetic complications. • Target blood pressure (≤140/80) reduces the risk of vascular complications and reduces the

progression of eye disease and kidney failure. • Target cholesterol (<5 mmol/L) reduces the risk of vascular complications.

Linkage to NDA was used to investigate the proportion of people in the NDFA cohort that had met the NICE treatment targets in the preceding NDA collection period (January 2013 to March 2014)36.

Table 24 below shows that a lower proportion of people presenting with a diabetic foot ulcer met the HbA1c treatment target (44.1 per cent) compared to the wider diabetes population (64.1 per cent), a difference of 20.0 percentage points. The difference was less pronounced for the blood pressure target (71.2 per cent compared to 73.8 per cent). There was no significant difference for cholesterol, except for people with Type 2 where attainment was slightly higher in those presenting with a foot ulcer (80.2 per cent compared to 77.8 per cent).

Table 24: Treatment target achievement recorded in the NDA, January 2013 – March 2014, England and Wales, NDFA patients first seen in 2014-2015^

Treatment target

All diabetes Type 1 Type 2 and other

NDFAi

NDAii

NDFAi

NDAii

NDFAi

NDAii

Per cent

Per cent

Per cent

Per cent

Per cent

Per cent

HbA1c ≤58 mmol/mol 44.1 64.1 19.3 29.4 47.8 66.8

BP ≤140/80 71.2 73.8 67.7 76.4 71.7 73.6

Cholesterol <5 mmol/L 78.7 77.4 69.3 71.5 80.2 77.8

Met all treatment targets* 28.9 39.9 11.6 18.6 31.4 41.4

* HbA1c ≤58 mmol/mol, cholesterol < 5 mmol/L and the blood pressure target ≤ 140/80. ^ Where the values in a row in the table are emboldened , the difference between the comparable NDFA and NDA percentages are statistically significant (p <0.05). i People with diabetes presenting with a foot ulcer.

ii All people with diabetes.

36

The January 2013 to March 2014 NDA cohort was used to ensure that NDA treatment target achievement took place prior to the NDFA attendance

63

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